Cleared Traditional

K852750 - TEGADERM PLUS TRANSPARENT DRESSING #952X

K852750 · 3M Company · General & Plastic Surgery device
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Sep 1985
Decision
84d
Days
-
Risk

K852750 is an FDA 510(k) clearance for the TEGADERM PLUS TRANSPARENT DRESSING #952X. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 K852750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received June 27, 1985
Decision Date September 19, 1985
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 221
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K852750.
BARD ABSORPTION DRESSING
K861024 · C.R. Bard, Inc. · Apr 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · Johnson & Johnson Professionals, Inc. · Mar 1986
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
K853844 · Convatec, A Division of E.R. Squibb & Sons · Nov 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147 · Beiersdorf, Inc. · Jul 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985