FPA
- Product code
- FPA
- Device name
- Set, Administration, Intravascular
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5440
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1174
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261530 | 2026-06-03 | Deka Research and Development | iiSure Infusion Set | |
| K252543 | 2026-05-04 | Amsino International, Inc. | AMSafe Administration Set (BA-70075, BA-70071-D, BA- | |
| K251375 | 2026-02-12 | Puracath Medical, Inc. | PuraCath Firefly Needleless Connector IT (9005) | |
| K251257 | 2025-12-04 | Np Medical | nSet+ Stabilization Set [6426733]; nSet+ Stabilizati | |
| K250325 | 2025-10-30 | Carefusion (Bd) | BD Alaris Pump Infusion Set | |
| K251814 | 2025-08-29 | Epic Medical Pte. , Ltd. | EZ IV Administration Set | |
| K251854 | 2025-08-06 | Tandem Diabetes Care | SteadiSet infusion set | |
| K243841 | 2025-08-01 | Deka Research and Development | Sparta Infusion Set for Insulin | FDA |
| K243392 | 2025-07-24 | B.Braun Medical, Inc. | Infusomat® Space Volumetric Infusion Pump Administra | |
| K250616 | 2025-06-05 | Icu Medical, Inc. | Clave Neutral-Displacement Needlefree Connectors | |
| K242692 | 2025-05-09 | Capillary Biomedical, LLC | SteadiSet Infusion Set | |
| K242763 | 2025-05-02 | Pfm Medical, Inc. | JetCan® Pro Safety Huber Needle | |
| K243529 | 2025-03-14 | Baxter Healthcare Corporation | Solution Administration Sets | |
| K242339 | 2025-02-28 | Baxter Healthcare Corporation | Intravascular Extension Sets and Accessories | |
| K241058 | 2024-12-18 | Quest Medical, Inc. | Lyka® PORT Needle Free Access Device (4170Y) | |
| K234129 | 2024-09-20 | Ecomed Solutions, LLC | Ecomed Disposable Administration Sets | |
| K242126 | 2024-08-22 | Bq Plus Medical Co., Ltd. | I.V. Administration Set | — |
| K232475 | 2024-05-10 | Shandong Zhushi Pharmaceutical Group C | Disposable infusion set with needle | FDA |
| K222766 | 2024-04-12 | Shandong Ande Healthcare Apparatus Co. | Disposable Extension Set | |
| K232328 | 2024-03-01 | Innovative Health Sciences, LLC | Insignis Syringe Infusion System | |
| K231707 | 2024-01-03 | Q For Plastic Industries | ResQ Administration Set | |
| K230528 | 2023-12-01 | Medcaptain Life Science Co., Ltd. | Extension Set | |
| K222780 | 2023-11-09 | Lily Medical Corporation | LILY Extension Tube and Needleless Connector | |
| K230343 | 2023-11-03 | Epic Medical Pte. , Ltd. | ProSeal Closed System Administration Set |
Official FDA classification page: FPA
Classification and pathway per current FDA publications. Data from openFDA (CC0).