Cleared Traditional

K940624 - 3M TEGASORB HYDROCOLLOID DRESSING

K940624 is an FDA 510(k) clearance for 3M TEGASORB HYDROCOLLOID DRESSING, manufactured by 3M Company. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K940624 · 3M Company · General & Plastic Surgery device
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May 1994
Decision
79d
Days
Class 1
Risk

K940624 is an FDA 510(k) clearance for the 3M TEGASORB 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 May 4, 1994 after a review of 79 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.

FDA 510(k) Submission Details - K940624

510(k) Number K940624 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 14, 1994
Decision Date May 04, 1994
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
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 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K940624.
COMFEEL PLUS WOUND DRESSING
K941263 · Richard Hamer Assoc., Inc. · May 1994
KTI HY-Q(TM) WOUND DRESSING
K940738 · Kingston Technologies, Inc. · May 1994
ALGINATE FIBER TOPICAL WOUND DRESSING
K940404 · Adri · May 1994
IODOFLEX PASTE
K940414 · Oclassen Pharmaceuticals, Inc. · Apr 1994
COMB-18 WOUND DRESSING
K936193 · Vsc Health Care Products · Apr 1994
KALTOGEL WOUND DRESSING
K940407 · Calgon Corp. · Apr 1994
K940624 · 3M TEGASORB HYDROCOLLOID DRESSING
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