FPB — Filter, Infusion Line Class II
FDA product code FPB covers "Filter, Infusion Line", 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
- FPB
- 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 |
|---|---|---|---|
| K261403 | Global Life Sciences Solutions Usa | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor | Aug 31, 2026 |
| K233277 | Hangzhou Qiantang Longyue Biotechnology Co | Filter Needle for Single Use | May 10, 2024 |
| K143583 | Merck Millipore | Cathivex ¿GV filter units | Aug 11, 2015 |
| K113227 | Baxter Healthcare | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 |
| K021293 | Arteria Medical Science | ARTERIA BLOOD FILTER | Aug 22, 2002 |
| K993379 | Pall | PALL SUPOR AEF FILTER | Dec 16, 1999 |
| K974661 | Sims Deltec | 0.2 U BACTERIAL FILTER | Feb 11, 1998 |
| K964283 | Arbor Technologies | AUTOPRIME | Jan 22, 1997 |
| K954331 | Pall Biomedical Products | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Jan 9, 1997 |
| K933523 | Mediziv Medical Products 1987 | I.V. FILTER SET | May 19, 1995 |
| K941628 | Douglas Medical Products | 40 MICRON BLOOD TRANSFUSION FILTER | Feb 16, 1995 |
| K942625 | Medi-Dose Group | 1.2 MICRON AIR ELIMINATING FILTER | Oct 7, 1994 |
| K943127 | Gelman Sciences | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Sep 29, 1994 |
| K942532 | Medi-Dose | 2 MICRON AIR ELIMINATING FILTER | Aug 17, 1994 |
| K941684 | Abbott Laboratories | IVEX-2 EXTENSION SET WITH Y-INJECTION SITE | Aug 3, 1994 |
| K942275 | Gelman Sciences | VIAL VENT FILTER | Jul 26, 1994 |
| K940980 | B. Braun Of America | CHARGED SUPOR(R) FILTER EXTENSION SET | Jul 14, 1994 |
| K933869 | Baxter Healthcare | EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER | Apr 26, 1994 |
| K940293 | Puritas Health Care | 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE | Mar 28, 1994 |
| K933294 | Aesculap | MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES | Feb 9, 1994 |