FDA product code · General Hospital
KMFBandage, Liquid
Product code KMF covers Bandage, Liquid, a Class I device regulated under 21 CFR 880.5090. FDA has cleared 222 devices in this code. Median review time across the 222 most recent decisions is 79 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 880.5090
- Review panel
- General Hospital
- Clearances
- 222
What is happening in KMF right now?
KMF (Bandage, Liquid): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in KMF?
FDA has cleared 222 devices under product code KMF since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin Protectant | Optmed, Inc. | |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | |
| K171148 | Aleo BME Liquid Bandage | Aleo Bme, Inc. | |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | |
| K160684 | Atteris No-Sting Skin Protectant | Rochal Industries, LLC | |
| K131384 | KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE | Kericure, Inc. | |
| K133443 | MARATHON NO STING LIQUID SKIN PROTECTANT | Advanced Medical Solutions (Plymouth), Ltd. | |
| K120059 | LIQUID BANDAGE | Chesson Laboratory Associates, Inc. | |
| K092712 | SKIN BARRIER FILM | Lodestar Products, Inc. | |
| K083087 | ECOCEL | Polichem S.A |
How long does FDA review take for KMF?
The median FDA review time for KMF is 79 days, measured across the 222 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KMF?
openFDA lists 4 recall records against product code KMF. A recall record covers one firm's corrective action and may span many device lots.
Z-1541-2022Open, ClassifiedFamily Dollar Stores, Llc.
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1453-2020TerminatedCardinal Health 200, LLC
Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.
Z-2748-2011TerminatedSmith & Nephew, Inc.
Smith & Nephew, Inc., St. Petersburg, FL is recalling multiple lot numbers of the following products: REMOVE Universal Adhesive Remover Wipes, UNI-SOLVE Adhesive Remover Wipes, SKIN-PREP Protective Wipes, PERI-PREP Protective Wipes, and NO-STING SKIN-PREP Protective Wipes. These products were manufactured by H&P Industries dba The Triad Group who has initiated a recall of products manufactured i
Z-0710-2007TerminatedColoplast Corp Skin Care Div
Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KMF?
MAUDE holds 24 adverse-event reports naming product code KMF, 8 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KMF unusual?
KMF does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
17 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in KMF?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KMF?
Across the 222 most recent decisions, these applicants filed most often in KMF.
| Applicant | Recent 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 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KMF
Get an email the morning anything changes in KMF — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.