Product code KGN: 510(k) clearances and predicates
Product code KGN covers ColActive Plus. FDA lists 192 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
192 clearances on file under product code KGN. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 12 |
| 2023 | 9 |
| 2024 | 13 |
| 2025 | 10 |
| 2026 so far | 13 |
Recent clearances
Newest KGN clearances in the FDA index, with applicant and decision date:
- K260652, ColActive Plus, applicant Covalon Technologies, Ltd., decided 2026-09-09. FDA record
- K260711, Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP), applicant Berkeley Advanced Biomaterials, decided 2026-08-27. FDA record
- K260596, Collagen Wound Powder, applicant Ventris Medical, decided 2026-07-02. FDA record
- K260669, Endoform Dermal Template, applicant Aroa Biosurgery , Ltd., decided 2026-06-24. FDA record
- K253521, ECMT-100 WMD, applicant Ecm Therapeutics, Inc., decided 2026-06-18. FDA record
- K253204, Catalyze, applicant BioTissue Holdings, Inc., decided 2026-06-05. FDA record
- K253974, Roosin Collagen Dressing, applicant Roosin Medical Co., Ltd., decided 2026-06-03. FDA record
- K254034, Roosin Collagen Powder, applicant Roosin Medical Co., Ltd., decided 2026-06-03. 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 Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP), Collagen Wound Powder. Watch new KGN 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 KGN?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KGN clearances include ColActive Plus.
How many 510(k) clearances use product code KGN?
192 at the time this page was generated, from openFDA records.
How do I find a predicate device under KGN?
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 KGN clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.