Cleared Traditional

K812678 - TEGADERM TRANSPARENT DRESSING

K812678 · 3M Company · General & Plastic Surgery device
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Jan 1982
Decision
125d
Days
-
Risk

K812678 is an FDA 510(k) clearance for the TEGADERM TRANSPARENT DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on January 25, 1982 after a review of 125 days - within the typical 510(k) review window.

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: 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.

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Submission Details

510(k) Number K812678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1981
Decision Date January 25, 1982
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
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 K812678.
DUODERM HYDROACTIVE GRANULES
K821655 · Convatec, A Division of E.R. Squibb & Sons · Oct 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K821656 · Convatec, A Division of E.R. Squibb & Sons · Sep 1982
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982
DRESSING CHANGE FOR G TUBE
K803115 · American Medical Disposable, Inc. · Jan 1981
HYPERALIMENTATION DRESSING CHANGE TRAY
K803114 · American Medical Disposable, Inc. · Dec 1980
I.V. START KIT
K780222 · Marion Laboratories, Inc. · Mar 1978