KMF · Class I · 21 CFR 880.5090

FDA Product Code KMF: Bandage, Liquid

Leading manufacturers include Optmed, 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

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 Review Time

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 →