Product code FPA
- Device name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026-09-11 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850017421585 | twiist | SEQUEL MED TECH, LLC | 2026-10-19 |
| 10885403520631 | BD Alaris Pump Infusion Set | BD Switzerland Sàrl | 2026-10-09 |
| 10885403533839 | BD Alaris Pump Infusion Set | BD Switzerland Sàrl | 2026-10-09 |
| 10885403533846 | BD Alaris Pump Infusion Set | BD Switzerland Sàrl | 2026-10-09 |
| 01081633602518 | WUSA6010 | NEOCHILD, LLC | 2026-10-08 |
| 10612479286013 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2026-10-06 |
| 10612479285993 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2026-10-06 |
| 04046955665075 | Extension Set | B. BRAUN MEDICAL INC. | 2021-02-08 |
| 04046955270347 | IV Administration Set | B. BRAUN MEDICAL INC. | 2019-02-22 |
| 04046955287475 | IV Administration Set | B. BRAUN MEDICAL INC. | 2018-10-05 |
| 04046955203307 | IV Administration Set | B. BRAUN MEDICAL INC. | 2018-06-15 |
| 04046964991257 | Extension Set | B. BRAUN MEDICAL INC. | 2017-04-03 |
| 00085412046433 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412080956 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412048963 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412049007 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412049014 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412051727 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412070056 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412071671 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412080949 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412046334 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412002583 | INTERLINK/DUO-VENT | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412002576 | INTERLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412036311 | Baxter | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412071688 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412046372 | CLEARLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412036380 | INTERLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 00085412036373 | INTERLINK | BAXTER HEALTHCARE CORPORATION | 2016-09-24 |
| 04046964296734 | Extension Set | B. BRAUN MEDICAL INC. | 2016-09-23 |