FPA — Set, Administration, Intravascular Class II
FDA product code FPA covers "Set, Administration, Intravascular", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FPA
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261530 | deka research and development | iiSure Infusion Set | June 3, 2026 |
| K252543 | amsino international | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, | May 4, 2026 |
| K251375 | puracath medical | PuraCath Firefly Needleless Connector IT (9005) | February 12, 2026 |
| K251257 | np medical | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre | December 4, 2025 |
| K250325 | carefusion (bd) | BD Alaris Pump Infusion Set | October 30, 2025 |
| K251814 | epic medical pte. | EZ IV Administration Set | August 29, 2025 |
| K251854 | tandem diabetes care | SteadiSet infusion set | August 6, 2025 |
| K243841 | deka research and development | Sparta Infusion Set for Insulin | August 1, 2025 |
| K243392 | b.braun medical | Infusomat® Space Volumetric Infusion Pump Administration Sets | July 24, 2025 |
| K250616 | icu medical | Clave Neutral-Displacement Needlefree Connectors | June 5, 2025 |
| K242692 | capillary biomedical | SteadiSet Infusion Set | May 9, 2025 |
| K242763 | pfm medical | JetCan® Pro Safety Huber Needle | May 2, 2025 |
| K243529 | baxter healthcare corporation | Solution Administration Sets | March 14, 2025 |
| K242339 | baxter healthcare corporation | Intravascular Extension Sets and Accessories | February 28, 2025 |
| K241058 | quest medical | Lyka® PORT Needle Free Access Device (4170Y) | December 18, 2024 |
| K234129 | ecomed solutions | Ecomed Disposable Administration Sets | September 20, 2024 |
| K242126 | bq plus medical co | I.V. Administration Set | August 22, 2024 |
| K232475 | shandong zhushi pharmaceutical group co | Disposable infusion set with needle | May 10, 2024 |
| K222766 | shandong ande healthcare apparatus co | Disposable Extension Set | April 12, 2024 |
| K232328 | innovative health sciences | Insignis Syringe Infusion System | March 1, 2024 |