Product code FRO: 510(k) clearances and predicates
Product code FRO covers Actolind® (06.3637. Actolind® Gel Plus). FDA lists 709 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
709 clearances on file under product code FRO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 9 |
| 2023 | 18 |
| 2024 | 24 |
| 2025 | 11 |
| 2026 so far | 17 |
Recent clearances
Newest FRO clearances in the FDA index, with applicant and decision date:
- K254168, Actolind® (06.3637. Actolind® Gel Plus), applicant ACTO GmbH, decided 2026-09-22. FDA record
- K254041, SkinSmart Antimicrobial HydroGel, applicant Magic Science Supply, LLC, decided 2026-09-11. FDA record
- K261646, Redermax® Antibacterial Wound Matrix, applicant Beijing Kreate Medical Co., Ltd., decided 2026-08-14. FDA record
- K253665, Vashe Plus Antimicrobial Solution, applicant Urgo Medical North America, LLC, decided 2026-08-11. FDA record
- K251929, SilverCeuticals® Antimicrobial Wound Gel, applicant Silverceuticals, Inc., decided 2026-06-24. FDA record
- K261023, Microdacyn Wound Irrigation Solution, applicant Sonoma Pharmaceuticals, Inc., decided 2026-06-24. FDA record
- K261638, Bonvadis®, applicant Oneness Biotech Co., Ltd., decided 2026-06-17. FDA record
- K254073, StatSeal Disc, applicant Merit Medical Systems, Inc., decided 2026-05-13. 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 SkinSmart Antimicrobial HydroGel, Redermax® Antibacterial Wound Matrix. Watch new FRO 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 FRO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FRO clearances include Actolind® (06.3637. Actolind® Gel Plus).
How many 510(k) clearances use product code FRO?
709 at the time this page was generated, from openFDA records.
How do I find a predicate device under FRO?
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 FRO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.