← Product Code [JOJ](/productcode/JOJ) · K261992

# 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992)

_Solventum US, LLC · JOJ · Sep 25, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K261992

## Device Facts

- **Applicant:** Solventum US, LLC
- **Product Code:** [JOJ](/productcode/JOJ.md)
- **Decision Date:** Sep 25, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.2800
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Indications for Use

The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other critical containment device to function as an independent monitor of critical parameters for the following sterilization cycles: Gravity 250°F/121°C 30 minutes; Gravity 270°F/132°C 3 minutes; Gravity 270°F/132°C 4 minutes; Gravity 270°F/132°C 10 minutes; Gravity 270°F/132°C 15 minutes; Gravity 270°F/132°C 25 minutes; Gravity 275°F/135°C 3 minutes; Gravity 275°F/135°C 10 minutes; Dynamic Air Removal 250°F/121°C 30 minutes; Dynamic Air Removal 270°F/132°C 4 minutes; Dynamic Air Removal 270°F/132°C 5 minutes; Dynamic Air Removal 270°F/132°C 6 minutes; Dynamic Air Removal 270°F/132°C 7 minutes; Dynamic Air Removal 270°F/132°C 8 minutes; Dynamic Air Removal 270°F/132°C 9 minutes; Dynamic Air Removal 270°F/132°C 10 minutes; Dynamic Air Removal 273°F/134°C 3 minutes; Dynamic Air Removal 273°F/134°C 4 minutes; Dynamic Air Removal 275°F/135°C 3 minutes.

## Device Story

Chemical indicator for steam sterilization monitoring; consists of paper wick and temperature-sensitive chemical pellet in paper/film/foil laminate. Pellet melts and migrates along wick upon exposure to steam, time, and temperature; migration visible through window marked ACCEPT or REJECT. Placed inside sterilization packs/trays by healthcare personnel. Provides visual confirmation of sterilization cycle parameters; failure to reach endpoint indicates potential sterilization failure. Benefits patient by ensuring sterility of processed instruments.

## Clinical Evidence

No clinical data. Bench testing only. Performance verified via saturated steam resistometer testing, simulated use testing, dry heat testing, and side-by-side comparison with biological indicators. All tests met acceptance criteria.

## Technological Characteristics

Chemical indicator; paper wick and proprietary chemical pellet in paper/film/foil laminate. Saturated steam-dependent migration mechanism. Dimensions/form factor not specified. No software, electronics, or connectivity. Shelf life: 3 years.

## Regulatory Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

## Predicate Devices

- 3M™ Attest™ Steam Chemical Integrator ([K220942](/device/K220942.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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![LOGO](U.S. Food & Drug Administration)

September 25, 2026

Solventum US, LLC
Heidi Wallis
Senior Regulatory Affairs Specialist
12930 Ih 10 W.
San Antonio, Texas 78249

Re: K261992

Trade/Device Name: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
Regulation Number: 21 CFR 880.2800
Regulation Name: Sterilization Process Indicator
Regulatory Class: Class II
Product Code: JOJ
Dated: June 12, 2026
Received: June 15, 2026

Dear Heidi Wallis:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261992 - Heidi Wallis

Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K261992 - Heidi Wallis

Page 3

Sincerely,

STEPHEN A. ANISKO -S Digitally signed by STEPHEN A. ANISKO -S Date: 2026.09.25 14:50:02 -04'00'

Stephen Anisko

Assistant Director

DHT4C: Division of Infection

Control Devices

OHT4: Office of Surgical and

Infection Control Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

510(k) Number (if known)

K261992

Device Name

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

Indications for Use (Describe)

The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other critical containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

|  Cycle | Type | Temperature Exposure Time  |
| --- | --- | --- |
|  Gravity | 250°F/121°C | 30 minutes  |
|  Gravity | 270°F/132°C | 3 minutes  |
|  Gravity | 270°F/132°C | 4 minutes  |
|  Gravity | 270°F/132°C | 10 minutes  |
|  Gravity | 270°F/132°C | 15 minutes  |
|  Gravity | 270°F/132°C | 25 minutes  |
|  Gravity | 275°F/135°C | 3 minutes  |
|  Gravity | 275°F/135°C | 10 minutes  |
|  Dynamic Air Removal | 250°F/121°C | 30 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 4 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 5 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 6 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 7 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 8 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 9 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 10 minutes  |
|  Dynamic Air Removal | 273°F/134°C | 3 minutes  |
|  Dynamic Air Removal | 273°F/134°C | 4 minutes  |
|  Dynamic Air Removal | 275°F/135°C | 3 minutes  |

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:

250°F/121°C 270°F/132°C 273°F/134°C 275°F/135°C

16.5 Minutes 2.0 Minutes 1.4 Minutes 1.2 Minutes

Type of Use (Select one or both, as applicable)

☐

Prescription Use (Part 21 CFR 801 Subpart D)

☑

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)

Page 1 of 2

PSC Publishing Services (301) 443-6740

EF

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 2 of 2

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[LOGO]

solventum

### 510(k) Summary

### for

### 3M™ Attest™ Steam Chemical Integrator

### 1243A, 1243B, 1243RE, 1243RES

Sponsor Information:

Solventum (previously 3M Health Care)

12930 IH 10 West

San Antonio, TX 78249

Contact: Heidi Wallis

Senior Regulatory Affairs Specialist

Phone Number: 651-381-2297

Date of Summary: September 24, 2026

510(k) Reference: K261992

Page 1 of 7

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# **1. Device Name and Classification:**

Common or Usual Name: Chemical Indicators  
Proprietary Name: 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)  
Classification Name: Physical/chemical sterilization process indicator Class II,  
Device Classification: 21 CFR § 880.2800(b)  
Product Code: JOJ

# **2. Predicate Device:**

K220942, 3M™ Attest™ Steam Chemical Integrator

# **3. Description of Device:**

3M™ Attest™ Steam Chemical Integrators are chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

# **4. Indications for Use**

The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

|  Cycle Type | Temperature | Exposure Time  |
| --- | --- | --- |
|  Gravity | 250°F/121°C | 30 minutes  |
|  Gravity | 270°F/132°C | 3 minutes  |
|  Gravity | 270°F/132°C | 4 minutes  |
|  Gravity | 270°F/132°C | 10 minutes  |
|  Gravity | 270°F/132°C | 15 minutes  |
|  Gravity | 270°F/132°C | 25 minutes  |
|  Gravity | 275°F/135°C | 3 minutes  |
|  Gravity | 275°F/135°C | 10 minutes  |
|  Dynamic Air Removal | 250°F/121°C | 30 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 4 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 5 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 6 minutes  |

Page 2 of 7

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|  Dynamic Air Removal | 270°F/132°C | 7 minutes  |
| --- | --- | --- |
|  Dynamic Air Removal | 270°F/132°C | 8 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 9 minutes  |
|  Dynamic Air Removal | 270°F/132°C | 10 minutes  |
|  Dynamic Air Removal | 273°F/134°C | 3 minutes  |
|  Dynamic Air Removal | 273°F/134°C | 4 minutes  |
|  Dynamic Air Removal | 275°F/135°C | 3 minutes  |

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:

|  250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C  |
| --- | --- | --- | --- |
|  16.5 Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes  |

Page 3 of 7

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# Technological Characteristic Comparison Table

|  Feature | Submission Device (K261992): 3M™ Attest™ Steam Chemical Integrator |   |   | Predicate Device (K220942): 3M™ Attest™ Steam Chemical Integrator |   |   | Comparison  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Device Models | 1243A, 1243B, 1243RE, 1243RES |   |   | 1243A, 1243B, 1243RE, 1243RES |   |   | Identical  |
|  Indications for use | The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: |   |   | The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles: |   |   | Identical  |
|   |  Cycle Type | Temperature | Exposure Time | Cycle Type | Temperature | Exposure Time  |   |
|   |  Gravity | 250°F/121°C | 30 minutes | Gravity | 250°F/121°C | 30 minutes  |   |
|   |  Gravity | 270°F/132°C | 3 minutes | Gravity | 270°F/132°C | 3 minutes  |   |
|   |  Gravity | 270°F/132°C | 4 minutes | Gravity | 270°F/132°C | 4 minutes  |   |
|   |  Gravity | 270°F/132°C | 10 minutes | Gravity | 270°F/132°C | 10 minutes  |   |
|   |  Gravity | 270°F/132°C | 15 minutes | Gravity | 270°F/132°C | 15 minutes  |   |
|   |  Gravity | 270°F/132°C | 25 minutes | Gravity | 270°F/132°C | 25 minutes  |   |
|   |  Gravity | 275°F/135°C | 3 minutes | Gravity | 275°F/135°C | 3 minutes  |   |
|   |  Gravity | 275°F/135°C | 10 minutes | Gravity | 275°F/135°C | 10 minutes  |   |
|   |  Dynamic Air Removal | 250°F/121°C | 30 minutes | Dynamic Air Removal | 250°F/121°C | 30 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 4 minutes | Dynamic Air Removal | 270°F/132°C | 4 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 5 minutes | Dynamic Air Removal | 270°F/132°C | 5 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 6 minutes | Dynamic Air Removal | 270°F/132°C | 6 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 7 minutes | Dynamic Air Removal | 270°F/132°C | 7 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 8 minutes | Dynamic Air Removal | 270°F/132°C | 8 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 9 minutes | Dynamic Air Removal | 270°F/132°C | 9 minutes  |   |
|   |  Dynamic Air Removal | 270°F/132°C | 10 minutes | Dynamic Air Removal | 270°F/132°C | 10 minutes  |   |

Page 4 of 7

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|  Feature | Submission Device (K261992): 3M™ Attest™ Steam Chemical Integrator |   |   |   | Predicate Device (K220942): 3M™ Attest™ Steam Chemical Integrator |   |   |   | Comparison  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | Dynamic Air Removal |   | 273°F/134°C | 3 minutes | Dynamic Air Removal |   | 273°F/134°C | 3 minutes |   |
|   |  Dynamic Air Removal |   | 273°F/134°C | 4 minutes | Dynamic Air Removal |   | 273°F/134°C | 4 minutes  |   |
|   |  Dynamic Air Removal |   | 275°F/135°C | 3 minutes | Dynamic Air Removal |   | 275°F/135°C | 3 minutes  |   |
|  Indicator Agent | Proprietary formulation. |   |   |   | Proprietary formulation. |   |   |   | Similar.  |
|  Sterilization method and cycles | Steam sterilization processes 250°F to 275°F (121°C to 135°C). |   |   |   | Steam sterilization processes 250°F to 275°F (121°C to 135°C). |   |   |   | Identical  |
|  Endpoint Specifications (Minimum Stated Values) | The minimum stated values for the 3M™ Attest™ Steam Chemical Integrators as determined using a resistometer are provided in the table below. |   |   |   | The minimum stated values for the 3M™ Attest™ Steam Chemical Integrators as determined using a resistometer are provided in the table below. |   |   |   | Identical  |
|   |  250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C | 250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C  |   |
|   |  16.5 Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes | 16.5 Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes  |   |
|  Shelf life | Three (3) years |   |   |   | Three (3) years |   |   |   | Identical  |

Page 5 of 7

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## 5. Nonclinical Testing Comparison to the Predicate Device

3M™ Attest™ Steam Chemical Integrators are identical to the previously cleared devices which are sold under the same tradename 3M™ Attest™ Steam Chemical Integrators (K220942). There has been no change to the device materials, performance specifications, or fundamental technology.

The results of performance testing on 3M™ Attest™ Steam Chemical Integrators demonstrate the device performs as intended in the claimed steam sterilization cycles.

Table 6.1: Summary of Nonclinical Testing

|  Test Name | Purpose | Acceptance Criteria |   | Results  |
| --- | --- | --- | --- | --- |
|  Stated Value (SV) Testing | To identify the critical parameters required to achieve a stated inactivation, by referring to a stated test organism with stated D and z values. The integrator must turn to “ACCEPT” end point at the stated value time and must also remain “REJECT” when exposed to conditions of -1°C/-15% set point of the SV time. All testing is completed in a saturated steam resistometer. Integrator temperature coefficient and correlation coefficient are calculated to confirm alignment to biological indicator performance. | SV at 250°F/121°C | ≥ 16.5 minutes | Pass  |
|   |   |  SV at 270°F/132°C | ≥ 2.0 minutes  |   |
|   |   |  SV at 273°F/134°C | ≥ 1.4 minutes  |   |
|   |   |  SV at 275°F/135°C | ≥ 1.2 minutes  |   |
|   |   |  Integrator temperature coefficient | 10 - 27°C  |   |
|   |   |  Correlation coefficient | ≥ 0.9  |   |
|  Health Care Facility Simulated Use Testing | Confirm integrators provide acceptable performance in cleared customer use sterilization cycles. | Device reaches “ACCEPT” endpoint reaction when exposed to customer use cycles. Device does not reach endpoint (“REJECT”) when exposed to failing conditions in customer use cycles. |   | Pass  |
|  Dry Heat Testing | Verify device requires the presence of saturated steam to turn to reach endpoint. | Endpoint must not be met following dry heat exposure at 140°C for 30 min. |   | Pass  |
|  Side-by-Side Testing with Biological Indicator | Confirm integrators are parallel in performance to biological indicators (BI). | Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated. |   | Pass  |
|  Endpoint Color Stability | Confirm endpoint color stability for samples exposed to passing and failing conditions in a steam resistometer. | Endpoint decision must remain unchanged after 6 months. |   | Pass  |

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# 6. Conclusion

Based on the intended uses, technological characteristics and non-clinical performance data, 3M™ Attest™ Steam Chemical Integrators are as safe, as effective, and performs at least as well as the predicate, Attest™ Steam Chemical Integrator cleared under K220942, Class II (CFR § 880.2800(b)), product code JOJ.

Page 7 of 7

---

**Source:** [https://fda-staging.innolitics.com/device/K261992](https://fda-staging.innolitics.com/device/K261992)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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