Cleared Traditional

K852614 - ATRAUM WOUND DRESSING

K852614 · Axiom Medical, Inc. · General & Plastic Surgery device
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Aug 1985
Decision
71d
Days
-
Risk

K852614 is an FDA 510(k) clearance for the ATRAUM WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Axiom Medical, Inc. (Paramount, US). The FDA issued a Cleared decision on August 30, 1985 after a review of 71 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 Axiom Medical, Inc. devices

FDA 510(k) Submission Details - K852614

510(k) Number K852614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1985
Decision Date August 30, 1985
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K852614.
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
K853844 · Convatec, A Division of E.R. Squibb & Sons · Nov 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 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
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985