Product code KMF: 510(k) clearances and predicates
Product code KMF covers TearRepair Liquid Skin Protectant. FDA lists 222 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
222 clearances on file under product code KMF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest KMF clearances in the FDA index, with applicant and decision date:
- K241916, TearRepair Liquid Skin Protectant, applicant Optmed, Inc., decided 2024-09-27. FDA record
- K182733, Rochal Bioshield Silicone Film, applicant Rochal Industries, LLC, decided 2019-06-27. FDA record
- K171148, Aleo BME Liquid Bandage, applicant Aleo Bme, Inc., decided 2018-01-12. FDA record
- K153571, Cavilon Advanced High Endurance Skin Protectant, applicant 3M Healthcare, decided 2016-08-23. FDA record
- K160684, Atteris No-Sting Skin Protectant, applicant Rochal Industries, LLC, decided 2016-07-26. FDA record
- K131384, KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE, applicant Kericure, Inc., decided 2014-08-07. FDA record
- K133443, MARATHON NO STING LIQUID SKIN PROTECTANT, applicant Advanced Medical Solutions (Plymouth), Ltd., decided 2014-07-10. FDA record
- K120059, LIQUID BANDAGE, applicant Chesson Laboratory Associates, Inc., decided 2012-05-17. 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 Rochal Bioshield Silicone Film, Aleo BME Liquid Bandage. Watch new KMF 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 KMF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KMF clearances include TearRepair Liquid Skin Protectant.
How many 510(k) clearances use product code KMF?
222 at the time this page was generated, from openFDA records.
How do I find a predicate device under KMF?
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 KMF clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.