FDA product code KMF: Bandage, Liquid
KMF is the FDA product code for bandage, liquid. It is a Class I device, regulated under 21 CFR 880.5090 and reviewed by the General and Plastic Surgery panel. FDA has cleared 222 510(k) submissions under KMF, 1 in the last five years, from 114 different applicants. The average 510(k) review took 135 days (median 79); 88 days on average over the last three years. FDA has posted 4 recalls for KMF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bandage, Liquid |
| Device class | Class I |
| Regulation | 21 CFR 880.5090 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KMF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 268 |
| 2019 | 1 | 272 |
| 2024 | 1 | 88 |
Compare with all 510(k) review times · Search every KMF clearance
Top KMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 13 | 1998-04-15 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 9 | 1997-12-10 |
| Bioderm, Inc. | 7 | 1999-05-18 |
| Smith & Nephew United, Inc. | 7 | 1996-10-25 |
| Innovative Technologies , Ltd. | 6 | 1998-09-08 |
109 more applicants have KMF clearances. See the full list in Caduvo.
Most recent KMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241916 | Optmed, Inc. | TearRepair Liquid Skin Protectant | 2024-09-27 | 88 |
| K182733 | Rochal Industries, LLC | Rochal Bioshield Silicone Film | 2019-06-27 | 272 |
| K171148 | Aleo Bme, Inc. | Aleo BME Liquid Bandage | 2018-01-12 | 268 |
| K153571 | 3M Healthcare | Cavilon Advanced High Endurance Skin Protectant | 2016-08-23 | 252 |
| K160684 | Rochal Industries, LLC | Atteris No-Sting Skin Protectant | 2016-07-26 | 137 |
Recalls for KMF devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-06-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code KMF?
KMF is the FDA product code for bandage, liquid. It is a Class I device, regulated under 21 CFR 880.5090 and reviewed by the General and Plastic Surgery panel.
What device class is KMF?
Class I, regulation 21 CFR 880.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code KMF?
Across 222 cleared submissions the average was 135 days from receipt to decision (median 79).
Which companies have the most KMF clearances?
Convatec, A Division of E.R. Squibb & Sons (13); Kendall Healthcare Products Co. Div.Of Tyco Health (9); Bioderm, Inc. (7); Smith & Nephew United, Inc. (7); Innovative Technologies , Ltd. (6).
Have KMF devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KMF
- Run a recall and safety report across every KMF manufacturer
- Watch product code KMF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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