FDA product code FPB: Filter, Infusion Line
FPB is the FDA product code for filter, infusion line. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 99 510(k) submissions under FPB, 2 in the last five years, from 49 different applicants. The average 510(k) review took 94 days (median 70); 174 days on average over the last three years. FDA has posted 8 recalls for FPB devices.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Infusion Line |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FPB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 224 |
| 2026 | 1 | 124 |
Compare with all 510(k) review times · Search every FPB clearance
Top FPB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 11 | 1994-08-03 |
| Tri-Med, Inc. | 8 | 1984-10-09 |
| Pall Biomedical Products Co. | 7 | 1997-01-09 |
| Baxter Healthcare Corp | 4 | 2011-12-08 |
| Travenol Laboratories, S.A. | 4 | 1987-04-17 |
44 more applicants have FPB clearances. See the full list in Caduvo.
Most recent FPB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261403 | Global Life Sciences Solutions USA, LLC | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | 2026-08-31 | 124 |
| K233277 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | Filter Needle for Single Use | 2024-05-10 | 224 |
| K143583 | Merck Millipore , Ltd. | Cathivex ¿GV filter units | 2015-08-11 | 236 |
| K113227 | Baxter Healthcare Corp | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | 2011-12-08 | 37 |
| K021293 | Arteria Medical Science, Inc. | ARTERIA BLOOD FILTER | 2002-08-22 | 121 |
Recalls for FPB devices
8 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-31.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code FPB?
FPB is the FDA product code for filter, infusion line. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is FPB?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code FPB?
Across 99 cleared submissions the average was 94 days from receipt to decision (median 70).
Which companies have the most FPB clearances?
Abbott Laboratories (11); Tri-Med, Inc. (8); Pall Biomedical Products Co. (7); Baxter Healthcare Corp (4); Travenol Laboratories, S.A. (4).
Have FPB devices been recalled?
Yes: 8 product recalls across 4 recall events; the most recent began 2021-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code FPB
- Run a recall and safety report across every FPB manufacturer
- Watch product code FPB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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