FPA — Set, Administration, Intravascular Class II
FDA Device Classification
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 |
|---|
| 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 |
| K231707 | q for plastic industries | ResQ Administration Set | January 3, 2024 |
| K230528 | medcaptain life science co | Extension Set | December 1, 2023 |