Cleared Traditional

3M TEGASORB THIN HYDROCOLLOID DRESSING (K982892) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K982892 · 3M Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
70d
Days
Class 1
Risk

K982892 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 Company (St. Paul, US). The FDA issued a Cleared decision on October 26, 1998 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

Submission Details

510(k) Number K982892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1998
Decision Date October 26, 1998
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K982892.
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3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
3M LIQUID BANDAGE, MODEL 120-LB
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ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998