KMF · Class I · 21 CFR 880.5090

FDA Product Code KMF: Bandage, Liquid

Leading manufacturers include Convatec, A Division of E.R. Squibb & Sons, Kendall Healthcare Products Co. Div.Of Tyco Health and Smith & Nephew United, Inc..

222
Total
222
Cleared
135d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Bandage, Liquid Devices (Product Code KMF)

222 devices
1–24 of 222
Cleared Sep 27, 2024
TearRepair Liquid Skin Protectant
K241916
Optmed, Inc.
General & Plastic Surgery · 88d
Cleared Jun 27, 2019
Rochal Bioshield Silicone Film
K182733
Rochal Industries, LLC
General & Plastic Surgery · 272d
Cleared Jan 12, 2018
Aleo BME Liquid Bandage
K171148
Aleo Bme, Inc.
General & Plastic Surgery · 268d
Cleared Aug 23, 2016
Cavilon Advanced High Endurance Skin Protectant
K153571
3M Healthcare
General & Plastic Surgery · 252d
Cleared Jul 26, 2016
Atteris No-Sting Skin Protectant
K160684
Rochal Industries, LLC
General & Plastic Surgery · 137d
Cleared Aug 07, 2014
KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE
K131384
Kericure, Inc.
General & Plastic Surgery · 450d
Cleared Jul 10, 2014
MARATHON NO STING LIQUID SKIN PROTECTANT
K133443
Advanced Medical Solutions (Plymouth), Ltd.
General & Plastic Surgery · 240d
Cleared May 17, 2012
LIQUID BANDAGE
K120059
Chesson Laboratory Associates, Inc.
General & Plastic Surgery · 129d
Cleared Feb 23, 2010
SKIN BARRIER FILM
K092712
Lodestar Products, Inc.
General & Plastic Surgery · 173d
Cleared Aug 07, 2009
ECOCEL
K083087
Polichem S.A
General & Plastic Surgery · 295d
Cleared Jul 31, 2009
CHESSON LABS LIQUID BANDAGE
K083913
Chesson Laboratory Associates, Inc.
General & Plastic Surgery · 213d
Cleared Feb 23, 2009
GLUSEAL 90, MODEL GLU9010
K083752
Glustitch, Inc.
General & Plastic Surgery · 68d
Cleared Oct 14, 2008
MRDH BANDAGE
K082703
Marine Polymer Technologies, Inc.
General & Plastic Surgery · 28d
Cleared May 20, 2008
NEUTROPHASE
K081009
Novabay Pharmaceuticals
General & Plastic Surgery · 42d
Cleared Jan 30, 2008
GELSPRAY WOUND DRESSING
K073663
Biocure, Inc.
General & Plastic Surgery · 35d
Cleared May 02, 2007
PRODERMA LIQUID BANDAGE
K063202
Procurement Technology Systems, LLC
General & Plastic Surgery · 194d
Cleared Mar 19, 2007
SILVERLON DIRECT PRESSURE WOUND DRESSING
K984207
Argentum International, LLC
General & Plastic Surgery · 3037d
Cleared Dec 11, 2006
BAND-AID(R) BRAND LIQUID BANDAGE
K062602
Johnson & Johnson Consumer Companies, Inc.
General & Plastic Surgery · 101d
Cleared Jun 19, 2006
CUTICOVER SKIN BARRIER DEVICE
K042955
D & D Holdings, LLC
General & Plastic Surgery · 601d
Cleared Jun 19, 2006
3M LIQUID BANDAGE
K053409
3M Company
General & Plastic Surgery · 194d
Cleared Feb 23, 2006
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
K050757
Chemence Medical, Inc.
General & Plastic Surgery · 337d
Cleared Nov 08, 2005
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
K051082
Medtrade Products , Ltd.
General & Plastic Surgery · 195d
Cleared Jun 25, 2004
ELASTIC SKIN LIQUID BANDAGE
K032948
Medpak, LLC
General & Plastic Surgery · 277d
Cleared May 17, 2004
RESTORE WOUND CLEANSER
K040779
Hollister, Inc.
General & Plastic Surgery · 52d

About Product Code KMF - Regulatory Context

510(k) Submission Activity

222 total 510(k) submissions under product code KMF since 1977, with 222 receiving FDA clearance (average review time: 135 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.