Product code FPA: 510(k) clearances and predicates
Product code FPA covers Ecomed Disposable Administration Sets. FDA lists 1175 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
1175 clearances on file under product code FPA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 14 |
| 2023 | 14 |
| 2024 | 7 |
| 2025 | 11 |
| 2026 so far | 4 |
Recent clearances
Newest FPA clearances in the FDA index, with applicant and decision date:
- K254123, Ecomed Disposable Administration Sets, applicant Ecomed Solutions, LLC, decided 2026-09-11. FDA record
- K261530, iiSure Infusion Set, applicant Deka Research and Development, decided 2026-06-03. FDA record
- K252543, 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), applicant Amsino International, Inc., decided 2026-05-04. FDA record
- K251375, PuraCath Firefly Needleless Connector IT (9005), applicant Puracath Medical, Inc., decided 2026-02-12. FDA record
- K251257, nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727], applicant Np Medical, decided 2025-12-04. FDA record
- K250325, BD Alaris Pump Infusion Set, applicant Carefusion (Bd), decided 2025-10-30. FDA record
- K251814, EZ™ IV Administration Set, applicant Epic Medical Pte. , Ltd., decided 2025-08-29. FDA record
- K251854, SteadiSet infusion set, applicant Tandem Diabetes Care, decided 2025-08-06. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include iiSure Infusion Set, 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). Watch new FPA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FPA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FPA clearances include Ecomed Disposable Administration Sets.
How many 510(k) clearances use product code FPA?
1175 at the time this page was generated, from openFDA records.
How do I find a predicate device under FPA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FPA clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.