KMF · Class I · 21 CFR 880.5090

FDA Product Code KMF: Bandage, Liquid

Leading manufacturers include 3M Company, Abbott Laboratories and Smith & Nephew, 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
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 Jun 19, 2006
3M LIQUID BANDAGE
K053409
3M Company
General & Plastic Surgery · 194d
Cleared Oct 07, 2003
3M LIQUID BANDAGE, MODEL 120-LB
K031263
3M Company
General & Plastic Surgery · 169d
Cleared Dec 10, 1998
ALGISITE M
K983210
Smith & Nephew, Inc.
General & Plastic Surgery · 87d
Cleared Oct 26, 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892
3M Company
General & Plastic Surgery · 70d
Cleared Oct 26, 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893
3M Company
General & Plastic Surgery · 70d
Cleared Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared May 04, 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624
3M Company
General & Plastic Surgery · 79d
Cleared Feb 05, 1982
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134
C.R. Bard, Inc.
General & Plastic Surgery · 18d
Cleared May 14, 1979
DRESSING, ENVIRON WOUND
K782008
Abbott Laboratories
General & Plastic Surgery · 164d
Cleared Sep 07, 1978
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406
Abbott Laboratories
General & Plastic Surgery · 24d
Cleared Apr 19, 1978
HYDRON BURN DISPOSABLE DISPENSER SET
K780616
Abbott Laboratories
General & Plastic Surgery · 6d
Cleared Aug 03, 1977
HYDRON BURN BANDAGE
K771321
Abbott Laboratories
General & Plastic Surgery · 16d

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 →