Product code OMP: 510(k) clearances and predicates
Product code OMP covers RENASYS DYNAFLOW Kit (66807741). FDA lists 215 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
215 clearances on file under product code OMP. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 10 |
| 2023 | 8 |
| 2024 | 9 |
| 2025 | 5 |
| 2026 so far | 7 |
Recent clearances
Newest OMP clearances in the FDA index, with applicant and decision date:
- K261338, RENASYS DYNAFLOW Kit (66807741), applicant Smith & Nephew Medical, Ltd., decided 2026-09-11. FDA record
- K253263, ConvaVAC™ Negative Pressure Wound Therapy System, applicant Convatec Limited, Gdc Building, decided 2026-06-24. FDA record
- K253199, CURASYS 2 (EMDN0003), applicant CG Bio Co., Ltd., decided 2026-06-23. FDA record
- K260646, RENASYS EDGE (66803126), applicant Smith & Nephew Medical, Ltd., decided 2026-05-27. FDA record
- K261291, Nisus NPWT Canister 500-mL (CPC-500), applicant Cork Medical, decided 2026-05-21. FDA record
- K254019, Wound Geni NPWT System, applicant Bechtel Medical, Inc., decided 2026-05-04. FDA record
- K253429, Genadyne ASTRA NPWT, applicant Genadyne Biotechnologies, Inc., decided 2026-03-12. FDA record
- K250586, Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory, applicant Deroyal Industries, Inc., decided 2025-11-21. 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 ConvaVAC™ Negative Pressure Wound Therapy System, CURASYS 2 (EMDN0003). Watch new OMP 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 OMP?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent OMP clearances include RENASYS DYNAFLOW Kit (66807741).
How many 510(k) clearances use product code OMP?
215 at the time this page was generated, from openFDA records.
How do I find a predicate device under OMP?
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 OMP clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.