Product code FPAClass 2
Set, Administration, Intravascular 510(k) Clearances
Product code FPA is the FDA classification for Set, Administration, Intravascular, a Class 2 device regulated under 21 CFR 880.5440, reviewed by the FDA General Hospital panel. FDA has cleared 1,174 510(k) submissions under this product code.
Every device cleared under product code FPA shares the same intended use and device type, so they are candidate predicate devices for a new 510(k) of this type. Open any device below to see its full clearance record and its candidate predicates.
- Cleared devices
- 1,174
- Device class
- Class 2
- Regulation
- 880.5440
- Latest clearance
- 2026-06-03
Cleared devices under product code FPA
Showing the 50 most recent of 1,174 cleared devices. Clearances from 2021-11-10 to 2026-06-03.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | Amsino International, Inc. | 2026-05-04 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 |
| K251814 | EZ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 |
| K242126 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2024-08-22 |
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024-05-10 |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | 2024-04-12 |
| K232328 | Insignis Syringe Infusion System | Innovative Health Sciences, LLC | 2024-03-01 |
| K231707 | ResQ Administration Set | Q For Plastic Industries | 2024-01-03 |
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | 2023-12-01 |
| K222780 | LILY Extension Tube and Needleless Connector | Lily Medical Corporation | 2023-11-09 |
| K230343 | ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. | 2023-11-03 |
| K221327 | BD Alaris Pump Infusion Sets | Care Fusion | 2023-07-21 |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | 2023-06-23 |
| K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi | 2023-06-16 |
| K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | 2023-06-09 |
| K220301 | Volumat Line | Fresenius Kabi | 2023-06-02 |
| K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | 2023-05-18 |
| K223101 | BD Secondary Infusion Set | Care Fusion | 2023-05-12 |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | Np Medical, Inc. | 2023-04-19 |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | 2023-04-12 |
| K223088 | BD SmartSite Needle-Free Connector | Care Fusion | 2023-04-07 |
| K222889 | FlowArt® Needle-Free Split Septum Valve | Asset Medikal Tasarim San Tic As. | 2023-01-20 |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 |
| K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | 2022-11-03 |
| K220267 | AMSafe NeuFlo Needleless Connector | Amsino International, Inc. | 2022-10-07 |
| K212262 | PCA Syringe Sets | Baxter Healthcare Corporation | 2022-10-03 |
| K221473 | Flowart | Asset Medikal Tasarim As. | 2022-09-26 |
| K221481 | NeutrArt | Asset Medikal Tasarim As. | 2022-09-23 |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc. | 2022-06-05 |
| K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022-06-02 |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | 2022-05-10 |
| K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | 2022-03-25 |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022-03-03 |
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022-01-18 |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Ivenix, Inc. | 2021-11-10 |
Filing a 510(k) for a Set, Administration, Intravascular of this type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.