FDA product code FPA: Set, Administration, Intravascular
FPA is the FDA product code for set, administration, intravascular. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 1,175 510(k) submissions under FPA, 50 in the last five years, from 476 different applicants. The average 510(k) review took 118 days (median 79); 217 days on average over the last three years. FDA has posted 1,089 recalls for FPA devices, 210 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, Administration, Intravascular |
| 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 FPA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 17 | 196 |
| 2018 | 4 | 177 |
| 2019 | 7 | 210 |
| 2020 | 10 | 323 |
| 2021 | 13 | 217 |
| 2022 | 14 | 227 |
| 2023 | 14 | 311 |
| 2024 | 7 | 258 |
| 2025 | 11 | 183 |
| 2026 | 4 | 211 |
Compare with all 510(k) review times · Search every FPA clearance
Top FPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 51 | 2013-10-08 |
| Abbott Laboratories | 30 | 2003-12-04 |
| Y | 28 | 1996-04-04 |
| Icu Medical, Inc. | 27 | 2025-06-05 |
| Sterling Medivations, Inc. | 24 | 2002-05-21 |
471 more applicants have FPA clearances. See the full list in Caduvo.
Most recent FPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254123 | Ecomed Solutions, LLC | Ecomed Disposable Administration Sets | 2026-09-11 | 266 |
| K261530 | Deka Research and Development | iiSure Infusion Set | 2026-06-03 | 26 |
| K252543 | Amsino International, Inc. | 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) | 2026-05-04 | 265 |
| K251375 | Puracath Medical, Inc. | PuraCath Firefly Needleless Connector IT (9005) | 2026-02-12 | 286 |
| K251257 | Np Medical | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | 2025-12-04 | 225 |
Recalls for FPA devices
1,089 product recalls in 230 recall events; 210 initiated in the last five years and 239 still open. Most recent: 2026-08-19.
| Year | Recalls |
|---|---|
| 2017 | 22 |
| 2018 | 8 |
| 2019 | 30 |
| 2020 | 149 |
| 2021 | 41 |
| 2022 | 25 |
| 2023 | 12 |
| 2024 | 50 |
| 2025 | 112 |
| 2026 | 10 |
Frequently asked questions
What is FDA product code FPA?
FPA is the FDA product code for set, administration, intravascular. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is FPA?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code FPA?
Across 1,175 cleared submissions the average was 118 days from receipt to decision (median 79).
Which companies have the most FPA clearances?
Baxter Healthcare Corp (51); Abbott Laboratories (30); Y (28); Icu Medical, Inc. (27); Sterling Medivations, Inc. (24).
Have FPA devices been recalled?
Yes: 1,089 product recalls across 230 recall events; the most recent began 2026-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FPA
- Run a recall and safety report across every FPA manufacturer
- Watch product code FPA 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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