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
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
88d
recently vs 135d historically
FDA 510(k) Cleared Bandage, Liquid Devices (Product Code KMF)
222 devices
Cleared
Sep 27, 2024
TearRepair Liquid Skin Protectant
Optmed, Inc.
General & Plastic Surgery
88d
Cleared
Jun 27, 2019
Rochal Bioshield Silicone Film
Rochal Industries, LLC
General & Plastic Surgery
272d
Cleared
Jan 12, 2018
Aleo BME Liquid Bandage
Aleo Bme, Inc.
General & Plastic Surgery
268d
Cleared
Jun 19, 2006
3M LIQUID BANDAGE
3M Company
General & Plastic Surgery
194d
Cleared
May 17, 2004
RESTORE WOUND CLEANSER
Hollister, Inc.
General & Plastic Surgery
52d
Cleared
Oct 07, 2003
3M LIQUID BANDAGE, MODEL 120-LB
3M Company
General & Plastic Surgery
169d
Cleared
Jan 28, 1999
ASKINA HYDROCOLLOID/THIN
B.Braun Medical, Inc.
General & Plastic Surgery
519d
Cleared
Dec 30, 1998
COMFEEL SEASORB DRESSING
Coloplast Corp.
General & Plastic Surgery
83d
Cleared
Dec 10, 1998
ALGISITE M
Smith & Nephew, Inc.
General & Plastic Surgery
87d
Cleared
Oct 26, 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
3M Company
General & Plastic Surgery
70d
Cleared
Oct 26, 1998
3M TEGASORB HYDROCOLLOID DRESSING
3M Company
General & Plastic Surgery
70d
Cleared
Apr 15, 1998
NONWOVEN PAD
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
50d
Cleared
Mar 09, 1998
NON-WOVEN COMPRESS
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
35d
Cleared
Feb 20, 1998
NONWOVEN DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
58d
Cleared
Feb 06, 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
88d
Cleared
Dec 10, 1997
KENDALL CURITY NON-ADHERING DRESSING
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
78d
Cleared
Dec 04, 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery
79d
Cleared
Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
Smith & Nephew, Inc.
General & Plastic Surgery
90d
Cleared
Oct 01, 1997
CONVATEC ODOR CONTROL WOUND DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
86d
Cleared
Aug 14, 1997
CONVATEC NON-ADHESIVE DRESSING
Convatec, A Division of E.R. Squibb & Sons
General & Plastic Surgery
72d
Cleared
Dec 31, 1996
TIELLE HYDROPOLYMER FOAM DRESSING
Johnson & Johnson Medical, Inc.
General & Plastic Surgery
85d
Cleared
Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
Smith & Nephew United, Inc.
General & Plastic Surgery
77d
Cleared
Nov 14, 1995
COMFEEL:ALGINATE FILLER
Coloplast Corp.
General & Plastic Surgery
22d
Cleared
Oct 06, 1995
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
Deroyal Industries, Inc.
General & Plastic Surgery
78d
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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - KMF Product Code
Recent submissions under KMF have taken an average of 88 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
KMF devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →