Cleared Traditional

K924280 - 3M TEGASORB THIN HYDROCOLLOID DRESSING

K924280 is an FDA 510(k) clearance for 3M TEGASORB THIN HYDROCOLLOID DRESSING, manufactured by 3M Health Care, Ltd.. The device is a Class 1 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K924280

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.

KMF Device Classification - Class 1, General Controls

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 154
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