Cleared Traditional

OIL EMULSION NON-ADHERING DRESSING (K850126) - FDA 510(k) Clearance

K850126 · Absorbent Cotton Co., Inc. · General & Plastic Surgery device
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Apr 1985
Decision
101d
Days
-
Risk

K850126 is an FDA 510(k) clearance for the OIL EMULSION NON-ADHERING DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Absorbent Cotton Co., Inc. (Valley Park, US). The FDA issued a Cleared decision on April 25, 1985 after a review of 101 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.

View all Absorbent Cotton Co., Inc. devices

Submission Details

510(k) Number K850126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date April 25, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K850126.
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982
TEGADERM TRANSPARENT DRESSING
K812678 · 3M Company · Jan 1982