Cleared Traditional

K924280 - 3M TEGASORB THIN HYDROCOLLOID DRESSING

K924280 is the FDA 510(k) clearance for 3M TEGASORB THIN HYDROCOLLOID DRESSING by 3M Health Care, Ltd.. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K924280 · 3M Health Care, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
260d
Days
Class 1
Risk

K924280 is an FDA 510(k) clearance for the 3M TEGASORB THIN HYDROCOLLOID DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 260 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Health Care, Ltd. devices

Submission Details

510(k) Number K924280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date May 12, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 115d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 71
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K924280.
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X
K930468 · 3M Health Care, Ltd. · Aug 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · Coloplast A/S · Mar 1993
CURITY CALCIUM ALGINATE WOUND DRESSING
K925001 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993