TruPress

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 Procerus Enterprises Julie Byars Co-Founder Ontogen Medtech 815 Ogden Ave. Lisle, Illinois 60532 Re: K254074 Trade/Device Name: TruPress Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS, DXG, FMF Dated: August 13, 2026 Received: August 14, 2026 Dear Julie Byars: 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. {1} K254074 - Julie Byars Page 2 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" (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 {2} K254074 - Julie Byars Page 3 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). Sincerely, STEPHEN C. BROWNING -S CDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K254074 Device Name TruPress Indications for Use (Describe) The Procerus TruPress is a single-use, sterile, disposable device intended for use on adult patients for direct measurement of arterial or venous pressure at the site where a compatible introducer needle is inserted while attached to the TruPress device. 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.** 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 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} 510(k) Summary Procerus Enterprises Procerus TruPress Page 1 of 7 A. Device Information: | Category | Comments | | --- | --- | | Sponsor: | Procerus Enterprises Jordan Cox 2505 E. 3300 S, Ste 202 Salt Lake City, UT 84124 (702)-469-0472 | | Correspondent Contact Information: | Julie Byars 815 Ogden Ave. Lisle, IL 60532 (901)-848-4010 | | Device Common Name: | Disposable Pressure Transducer | | Device Regulation & Name: | 21 CFR 870.2850 – Extravascular blood pressure transducer 21 CFR 870.1435 – Single-function, preprogrammed diagnostic computer 21 CFR 880.5860 – Syringe, Piston | | Classification & Product Code: 510(k) Number: | Class II, DRS K254074 | | Device Proprietary Name: | Procerus TruPress | Predicate Device Information: | Predicate Device: | Compass Disposable Pressure Transducer | | --- | --- | | Predicate Device Manufacturer: | Compass (Mirador) | | Predicate Device Common Name: | Disposable Pressure Transducer | | Predicate Device Premarket Notification #: | K101518 | | Predicate Device Classification & Name: | 21 CFR 870.2850 – Extravascular blood pressure transducer 21 CFR 870.1435 – Single-function, preprogrammed diagnostic computer | | Predicate Device Classification & Product Code: | Class II, DRS | Reference Device Information | Reference Device: | Nipro Syringe | | --- | --- | | Reference Device Manufacturer: | Nipro | | Reference Device Common Name: | Piston Syringe | | Reference Device Premarket Notification #: | K191359 | | Reference Device Classification & Name: | 21 CFR 880.5860 – Syringe, Piston | K254074 {5} 510(k) Summary Procerus Enterprises Procerus TruPress Page 2 of 7 | Reference Device Classification & Product Code: | Class II, FMF | | --- | --- | ### B. Date Summary Prepared August 13 \( ^{th} \) , 2026 ### C. Description of Device The Procerus Enterprises TruPress is a battery-powered pressure transducer. It is single-use, disposable, and is provided sterilized with Ethylene Oxide (EO). It contains an embedded pressure sensor that is designed to measure either arterial or venous pressure in the integrated syringe fluid column. The device is compatible with heparinized saline and blood and is designed to connect to a compatible 1 inch introducer needle via a luer lock connection. It may be used in the OR, ER, or clinic room for point in time pressure measurements. ### D. Indications for Use The Procerus TruPress is a single-use, sterile, disposable device intended for use on adult patients for direct measurement of arterial or venous pressure at the site where a compatible introducer needle is inserted while attached to the TruPress device. ### E. Comparison of Technological Characteristics | Models | Procerus TruPress | Compass Disposable Pressure Transducer (Predicate Device) | Justification for why differences do not raise new questions of safety and effectiveness | | --- | --- | --- | --- | | 510(k) Number | K254074 | K101518 | N/A | | Indications for use | The Procerus TruPress is a single-use, sterile, disposable device intended for use on adult patients for direct measurement of arterial or venous pressure at the site where a compatible introducer needle is inserted while attached to the TruPress device. | The Compass Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure. | The predicate device includes an additional indication for direct measurement and monitoring of intracranial pressure. The TruPress is indicated for direct measurement of arterial and venous pressure only. This indication falls within the broader intended use of invasive blood pressure monitoring claimed by the predicate. The TruPress represents a subset of the predicate device indication and therefore does not introduce a new intended use and does not affect safety and effectiveness. | K254074 {6} 510(k) Summary Procerus Enterprises Procerus TruPress Page 3 of 7 | | | The Compass Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure. | The predicate device is indicated for measurement and monitoring of pressure. The TruPress is only indicated for direct pressure measurement. The intended use of the TruPress is narrower and therefore does not introduce a new intended use and does not affect safety and effectiveness. | | --- | --- | --- | --- | | Prescription/over the counter | Prescription | [Same] | [Same] | | Device Classification | Class II: 21 CFR 870.2850 21 CFR 870.1435 21 CFR 880.5860 | [Same] [Same] [Same] | [Same] [Same] [Same] The TruPress includes an additional device classification 21 CFR 880.5860 for the product code FMF (Piston Syringe), as the device includes syringe architecture. This technical difference is captured by the Nipro Syringe reference device (510(k) #: K191359). | | Single use | Yes | [Same] | [Same] | | Battery or Mains powered | Battery Power, 3V lithium manganese dioxide coin cell | Battery Power, 3V lithium ion coin cell | Both devices contain 3V coin cell batteries. TruPress is compliant with the applicable battery safety standard for the battery chemistry. IEC 60086-4 Primary batteries - Part 4: Safety of lithium batteries. | | Pressure Sensor Type | Embedded | [Same] | [Same] | | Accelerometer | Embedded | Not included | The TruPress contains two additional sensors, an accelerometer and a hall sensor. The pressure compensation calculations using additional sensors do not raise new questions of safety and effectiveness as demonstrated by benchtop verification testing. | K254074 {7} 510(k) Summary Procerus Enterprises Procerus TruPress Page 4 of 7 | Hall Sensor | Embedded | Not included | | | --- | --- | --- | --- | | Compensation | 1in needle | Not included | The TruPress software compensates for the measured pressure at the stopper, assuming the fluid head height of a 1in needle attached to the luer. It is unknown if the predicate includes any pressure compensation, but as the pressure sensor is within the fluid path, the user is required to level the predicate device for accurate readings. As the TruPress has a variable fluid height, the length of the attached needle is required to be accounted for to maintain accuracy. A note has been added to the IFU technical description, stating that the accuracy specified is defined using a 1in needle, and that use of other length needles can offset the accuracy of the measurements. Additionally, step 4 of the IFU instructs users to attach the TruPress to luer lock of a one-inch introducer needle. A warning has been added after step 4 stating “Device accuracy assumes a 1in needle length. Use of needle lengths greater than 2in may result in inaccuracies greater than ±4mmHg.” As the intended use of the TruPress is direct measurement of arterial or venous pressure, variances in pressure by this amount would be negligible for the user to determine if they are in a vein or artery. | | Luer Type | Male Luer Lock | Male Luer Lock and Female Luer Lock | The male luer lock of the TruPress and the predicate both connect to standard needles for access to the bloodstream. The predicate contains a female luer lock to connect to a syringe, while the TruPress has an integrated syringe and therefore does not require the female luer lock. | K254074 {8} 510(k) Summary Procerus Enterprises Procerus TruPress Page 5 of 7 | Fluid column | Incorporated into the device via syringe | Requires attachment (e.g. Needle, syringe, or catheter) | Both devices require attachment via luer lock to access the bloodstream. The TruPress has an integrated syringe, while the predicate requires the user to attach to an external syringe. Both devices maintain the same fluid-fluid pressure transmission pathway principle, where pressure is transmitted through a fluid column to the sensor and therefore does not create new questions of safety or effectiveness for generating a fluid column for pressure measurement. | | --- | --- | --- | --- | | Unit of Measurement | mmHg | [Same] | [Same] | | Pressure Range | 0mmHg to +200mmHg | -199mmHg to +999mmHG | The pressure range of the TruPress is limited to expected venous and arterial pressures. The predicate device has a wider pressure range but also has multiple additional indications that are not included for the TruPress. It is acceptable that the TruPress has a narrower pressure range than the predicate as it is representative of the intended use case. | | Resolution | 1mmHg | 1mmHg | [Same] | | Device Accuracy | ±2 mmHg from 0-66 mmHg and ± 3% of reading from 67-200 mmHg. | ±4 mmHg below 100 mmHg ± 4% of reading above 100 mmHg | The device accuracy range of the TruPress is more accurate than the device accuracy range of the predicate. The TruPress is able to more accurately detect changes in pressure during direct measurement of arterial or venous pressure and therefore does not raise new questions of safety or effectiveness. | | Device activation | Button – On | Button – On/Off | Both devices require the press of a button to power on. The TruPress automatically powers off after 20 hours, while the predicate powers off with a button press. As both devices are for single use only and would be expected to be disposed of after use, it is acceptable that the TruPress has a different mechanism for powering off the device. | | Sterilization Method | EO | [Same] | [Same] | K254074 {9} 510(k) Summary Procerus Enterprises Procerus TruPress Page 6 of 7 # F. Discussion of Performance Testing The following performance data were provided in support of the substantial equivalence determination. # BIOCOMPATIBILITY TESTING The sensor, stopper, interior of the barrel and barrel lubricant are the patient-contacting material used in the Procerus device. A biological risk assessment was conducted for the device. It considers raw material, manufacturing processing, and full endpoint biocompatibility testing performed, and determines full compliance of the device with ISO 10993-1. # ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC) Electrical safety and EMC testing were conducted on the Procerus device. The system complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 and 60601-4-2 standards for EMC. # SOFTWARE VERIFICATION TESTING Software verification was conducted on the firmware responsible for the device activation, display of pressure measurements, and pressure measurement calculations. All software verification testing activities were completed and passed successfully. # PERFORMANCE TESTING The following performance tests were conducted. Results demonstrated that the pressure measurement device meets all design specifications and requirements. - Extraneous Matter - Dead Space - Equilibration Time - Accuracy - Pressure Range - Fit of the stopper and plunger in the barrel - Screen Protector Peeling - Simulated Use - Force to Operate Piston - Liquid Leak - Air Leak - Electrical Safety (Basic Safety and Essential performance) - EMC Testing (Basic Safety, Essential Performance, Electromagnetic disturbances) - Sterile Hypodermic Syringe Testing - ISO 7886-1 Testing - ANSI/AAMI BP22:1994 (R2016) Testing - IEC 60601-2-34 Edition 4.0 2024-10 Testing - ISO 80369-7:2021 Testing K254074 {10} 510(k) Summary Procerus Enterprises Procerus TruPress Page 7 of 7 # ANIMAL STUDY A GLP animal study was conducted. The swine model was selected due to the similarity of anatomy and function of cardiac systems to those of humans. The study demonstrated that Users (Test Device Evaluators) could safely use the TruPress without causing adverse events and could accurately differentiate between venous and arterial locations. The study demonstrated agreement between the readings of the TruPress and predicate device when both devices were placed in the same vascular location. # CLINICAL STUDIES Clinical testing was not performed. # G. Conclusion The Procerus TruPress has been demonstrated to be as safe and effective as the predicate device. Performance testing, biocompatibility testing, software testing, EMC testing, and animal study testing confirm that the TruPress device meets its intended use without raising new questions of safety or effectiveness. Based on the information provided, Procerus TruPress is substantially equivalent to the predicate device. Safety and effectiveness information about the Procerus TruPress will be made available to any interested person upon request. K254074