Ecomed Disposable Administration Sets

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Ecomed Solutions, LLC David Yurek CEO 2910 Falling Waters Blvd. Lindenhurst, Illinois 60046 Re: K254123 Trade/Device Name: Ecomed Disposable Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 14, 2026 Received: August 14, 2026 Dear David Yurek: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254123 - David Yurek Page 2 FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. 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 {2} K254123 - David Yurek Page 3 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). Sincerely, GANG PENG -S Gang Peng for David Wolloscheck Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology 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) K254123 Device Name Ecomed Disposable Administration Sets Indications for Use (Describe) Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. 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 K254123 # K254123 510K SUMMARY Prepared on: 9-11-2026 ## CONTACT DETAILS Applicant Name: Ecomed Solutions, LLC Applicant Address: 2910 Falling Waters Blvd, Lindenhurst, IL 60046 Applicant Contact Telephone: 847-984-0106 Applicant Contact: Mr. David Yurek Applicant Contact Email: david.yurek@ecomed-solutions.com Correspondent Name: Ecomed Solutions, LLC Correspondent Address: 2910 Falling Waters Blvd, Lindenhurst, IL 60046 Correspondent Contact Telephone: 262-220-3463 Correspondent Contact: Ms. Christina Bloxton Correspondent Contact Email: christina.bloxton@ecomed-solutions.com ## 1.1 DEVICE NAME Device Trade Name: Ecomed Disposable Administration Sets Classification Name: Set, Administration, Intravascular Regulation Number: 880.5440 Product Code(s): FPA Device Class: Class II ## 1.2 LEGALLY MARKETED PREDICATE DEVICES Predicate: K234129, Ecomed Disposable Administration Sets ## 1.3 DEVICE DESCRIPTION SUMMARY The Ecomed Disposable Administration Sets are a family of sterile, single use gravity sets composed of common components that are used to administer fluids. A standalone needle free connector within the product family is a sterile, single use, high-pressure infusion capable device. Each set is comprised of a subset of common components which are broadly used throughout industry including roller clamp, slide clamp, a flow regulator, a drip chamber, an infusion line filter, {5} 510(k) Summary K254123 fluid delivery tubing, Burette w/ needle-free injection site and vent/cap and drip chamber, injection site, connectors between parts of the set, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. This family of sets and components is broken down into the following main categories: Primary set, Tee set, Flow Controller Set, Filter Set, Burette Set, extension set, and a standalone needle free connector. The range of set lengths is 6 (Tee Set) inches to 103 inches (Primary Set). The burette is graduated in mL. All set categories are intended for gravity administration. The standalone needle free connector is also intended for use with high-pressure infusion systems. This 510(k) includes additional US clearance is for an expanded portfolio of products with alternate components. The alternate components included in this submission are different needle-free connectors, a bifurcated connector, and a change in tubing material vendor for the same material type. Table 1: Side by side comparison of device categories included in this 510(k) | | Primary Set: | Tee Set | Flow Controller Set | Filter Set | Burette Set | Microbore Extension Set | Standalone NF Connector | | --- | --- | --- | --- | --- | --- | --- | --- | | Ecomed Part Number | ECO248006 | ECO248010 | ECO248008 | ECO248007 | ECO248009 | ECO248005 | ECO248011 | | Clearance Status | Same configuration as K234129 with new y-site. | Same configuration as K234129 with new NF Adapter | Same configuration as K234129 with Changes to New Y-Site, Tubing Diameter Change | Same configuration as K234129 with Changes to New Y-Site, Tubing Diameter Change | Same configuration as K234129 with Changes to New Y-Site, Tubing Diameter Change, Add NF Adapter | New Extension Set w/ NF Adapter | Standalone NF Connector | ### 1.4 INTENDED USE/INDICATIONS FOR USE Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. ### 1.5 INDICATIONS FOR USE COMPARISON Ecomed Disposable Administration sets are used to transfer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. {6} 510(k) Summary K254123 ### 1.6 TECHNOLOGICAL COMPARISON Table 2: Substantial Equivalence Comparison | Identification | | Proposed Device | Predicate Device | Explanation of Variation | | --- | --- | --- | --- | --- | | Name | | Ecomed Disposable Administration Sets | Ecomed Disposable Administration Sets (cleared K234129) | | | **Technology** | Anatomical sites | Peripheral Intravenous | Peripheral Intravenous | Same. | | | Contact Type | External communicating device -blood path, indirect | External communicating device -blood path, indirect | Same. | | | Contact duration | Prolonged 24hours < 30 days | Prolonged 24hours < 30 days | Same. | | | Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same. | | | Storage conditions | General warehouse. | General warehouse. | Same. | | | Shelf Life | 2 years | 2 years | Same. Shelf life is based on sterile barrier packaging which is unchanged from K234129. Impact Analysis assesses how each change is impacted by aging; all results passed. Performance testing completed after the end of shelf life per applicable sections of ISO 8536-4, ASNI/AAMI CN27, and modified . | | | Use Life | 7 days | 5 days | Different. Use life is based on microbial ingress testing, new testing has been submitted for the new component. Microbial ingress testing substantiates the 7 day use life. | | | Performance | ISO 8536-4 | ISO 8536-4 | Same. | {7} 510(k) Summary K254123 | Identification | | Proposed Device | Predicate Device | Explanation of Variation | | --- | --- | --- | --- | --- | | Name | | Ecomed Disposable Administration Sets | Ecomed Disposable Administration Sets (cleared K234129) | | | | Mode of fluid delivery | Gravity [The standalone needle-free connector is able to be used for pressure injection.] | Gravity | Same. (all sets except the Standalone Needle-Free Connector) Different. (Standalone Needle-Free Connector only) The Standalone Needle-Free Connector testing demonstrates power injector compatibility ≤325 psi for 10 seconds . | | | Control mechanism | Roller Clamp ABS Slide Clamp PE Flow Regulator PE ISO 8536-4 ISO 8536-13 ISO 8536-14 ISO 10993-1 | Roller Clamp ABS Slide Clamp PE Flow Regulator PE ISO 8536-4 ISO 8536-13 ISO 8536-14 ISO 10993-1 | Same. There are no changes to these components. | | | Tubing (ID X OD) | 3mm x 4mm 2.64mm x 3.8mm 0.8mm x 2.4mm ISO 8536-4 ISO 10993-1 | 3mm x 4mm 0.8mm x 2.4mm ISO 8536-4 ISO 10993-1 | Different. Additional size tubing added within the previous range of tubing. Impact Analysis addresses how each change was verified to meet the applicable requirements; all results passed. Performance testing was completed on both unaged and aged product per applicable sections of ISO 8536-4. | | | Injection site (needle-free) | Needle Free Valve E851 Needle Free Y-site N435 ISO 8536-4 ANSI/AAMI CN 27 ISO 10993-1 | Y injection site Adapter: PC & ABS with silicone port ISO 8536-4 ANSI/AAMI CN 27 ISO 10993-1 | Different. The needle-free injection site is changed to a different component which is standardized to ISO 8536-4 & ANSI/AAMI CN 27. Performance and microbial ingress testing per the standards for the Needle-Free Y-site (E851) passed. The Needle-Free valve (N435) is separately cleared by NP Medical via k251257 | {8} 510(k) Summary K254123 | Identification | | Proposed Device | Predicate Device | Explanation of Variation | | --- | --- | --- | --- | --- | | Name | | Ecomed Disposable Administration Sets | Ecomed Disposable Administration Sets (cleared K234129) | | | | Injection site (needle) | T injection site ABS with polyisoprene port ISO 8536-4 ISO 10993-1 | T injection site ABS with polyisoprene port ISO 8536-4 ISO 10993-1 | Same. There are no changes to this component. | | | Drip chamber | 60 drop ABS & PVC 20 drop ABS & PVC Fiberglass vent ISO 8536-4 ISO 10993-1 | 60 drop ABS & PVC 20 drop ABS & PVC Fiberglass vent ISO 8536-4 ISO 10993-1 | Same. There are no changes to this component. | | | filter | .2 um Acrylic and Polyester (PES) / Polytetrafluoroethylene (PTFE) ISO 8536-4 ISO 10993-1 | .2 um Acrylic and Polyester (PES) / Polytetrafluoroethylene (PTFE) ISO 8536-4 ISO 10993-1 | Same. There are no changes to this component. | | | Burette | PETG + ABS + PVC ISO 8536-5 ISO 10993-1 | PETG + ABS + PVC ISO 8536-5 ISO 10993-1 | Same. There are no changes to this component. | | | Spike | ABS ISO 8536-4 ISO 10993-1 | ABS ISO 8536-4 ISO 10993-1 | Same. There are no changes to this component. | | | Check valve | PC, Silicone ISO 8536-12 ISO 10993-1 | PC, Silicone ISO 8536-12 ISO 10993-1 | Same. There are no changes to this component. | | | Connectors | Luers (male, female) Female Luer: PC Male Luer Lock: ABS Rotating Male Luer: PVC, PC ISO 594/ISO 80369-7 ISO 10993-1 | Luers (male, female) Female Luer: PC Male Luer Lock: ABS Rotating Male Luer: PVC, PC ISO 594/ISO 80369-7 ISO 10993-1 | Same. There are no changes to this component. | | | Bifurcated tubing connector | Bifuse Connector (microbore only) | None. | Different. There is not a new function, as previously sets could be combined through a y-site to create a y shaped set. This component allows for a bonded y-shaped set. This is a bonded tubing component | {9} 510(k) Summary K254123 | Identification | | Proposed Device | Predicate Device | Explanation of Variation | | --- | --- | --- | --- | --- | | Name | | Ecomed Disposable Administration Sets | Ecomed Disposable Administration Sets (cleared K234129) | | | | | | | similar to other bonded tubing components within the predicate. The Bifurcated tubing connector connects tubing to other tubing to create y splits within the tubing set. The bifurcated connector does not connect to other components nor is it able to disconnect. Impact Analysis addresses how each change was verified to meet the applicable requirements; all results passed. Performance testing was completed on both unaged and aged product per applicable sections of ISO 8536-4. | | | Priming volume | Primary Set: 12.9 mL Burette Set: 10.1 mL Extension Set: 1.4, 2.1, & 18.5mL Tee Set: 0.5 mL Flow Control Set: 2.1 mL Needle free connector 0.04 mL | Primary Set: 12.9 mL Burette Set: 10.1 mL Extension Set: 2.7 mL Tee Set: 0.5 mL Flow Control Set: 3.2 mL | Different. Set sizing is based on clinical uses and priming volume is size based. Method of determining priming volume is unchanged. | | | Residual Volume in Needless Access Port | Needle Free Valve E851: 0.04 mL Needle Free Y-site N435: 0.1 mL ISO 8536-4 ANSI/AAMI CN 27 ISO 10993-1 | MicroClave: 0.04 mL ISO 8536-4 ANSI/AAMI CN 27 ISO 10993-1 | Different. The needle-free injection sites are changed to different components which are standardized to ISO 8536-4 & ANSI/AAMI CN 27. ANSI/AAMI CN 27 test report substantiates the residual volume of the Needle Free valve (E851). The Needle-Free valve (N435) is separately cleared by NP Medical via K251257. | | | Drops/mL | 60 drop ABS & PVC 20 drop ABS & PVC | 60 drop ABS & PVC 20 drop ABS & PVC | Same. There are no changes to these components. | {10} 510(k) Summary K254123 | Identification | | Proposed Device | Predicate Device | Explanation of Variation | | --- | --- | --- | --- | --- | | Name | | Ecomed Disposable Administration Sets | Ecomed Disposable Administration Sets (cleared K234129) | | | | | Fiberglass vent ISO 8536-4 ISO 10993-1 | Fiberglass vent ISO 8536-4 ISO 10993-1 | | | | Tubing Material | PVC | PVC | Different. The tubing is the same material type and grade, from a different vendor. The biocompatibility summary table indicates which materials are applicable from each 510(k) submission and Biocompatibility test reports with the new material show there are no increased biocompatibility risks. | | | length | Up to 103 inches | Up to 103 inches | Same. | ### 1.7 NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY & CONCLUSIONS # **Performance Testing:** The sterile single use Ecomed Disposable Administration Sets described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards: - ISO 8536-4 :2019, Infusion equipment for Medical Device Use- Part 4: Infusion sets for single use gravity feed. - ISO 8536-5:2004 Burette infusion sets for single use, gravity feed. - ISO 8536-12:2021 Infusion equipment for medical use — Part 12: Check valves for single use - ISO 8536-13:2016 Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact - ISO 8536-14:2016 Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact - ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications - ANSI/AAMI CN27:2021 General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications # **Sterilization, Packaging, Shelf-life Testing:** {11} 510(k) Summary K254123 Sterilization is validated per ISO 11135: 2014: the device is sterilized via ethylene oxide (EO) with a minimum Sterility Assurance Level of SAL of 10-6. EO residuals were evaluated per ANSI/AAMI/ISO 10993-7:2008 and found to be acceptable. - The products have a 2 year shelf-life that is confirmed via accelerated aging executed via ASTM F1980-07 (Reapproved 2011), standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing. - Sterile Barrier Packaging Testing performed on the proposed subject device in accordance with ISO 11607-1 packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)] including the following tests: - Visual inspection - Seal strength - Dye penetration Microbial ingress testing for the needle-free access site was performed as per ANSI AAMI CN27 Annex B.17 for microbial ingress testing. ### Biocompatibility testing: The biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "External communicating device -blood path, indirect" per section 5.2.2(a). The device will have prolonged contact is likely to exceed 24 hours but not 30 days. Testing completed on this device includes: - Cytotoxicity - Sensitization - Irritation - Acute Toxicity - Pyrogenicity - Hemocompatibility Modified drug solution particulate test USP <788> was completed to confirm device particulate level. ### Conclusion: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The new versions of the Ecomed Disposable Administration Set devices are substantially equivalent to the Ecomed Disposable Administration Set devices included in K234129 with respect to the indications for use, target population, and technological characteristics.