Cleared Traditional

ACRYDERM ABSORBENT OXYGEN DRESSING (K082459) - FDA 510(k) Clearance

K082459 · Acrymed, Inc. · General & Plastic Surgery device

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Sep 2008

Decision

24d

Days

Risk

K082459 is an FDA 510(k) clearance for the ACRYDERM ABSORBENT OXYGEN DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on September 19, 2008 after a review of 24 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 Acrymed, Inc. devices

Submission Details

510(k) Number	K082459 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 26, 2008
Decision Date	September 19, 2008
Days to Decision	24 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

91d faster than avg

Panel avg: 115d · This submission: 24d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

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Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K082459

Acrymed, Inc.

Beaverton, OR · US

BRUCE GIBBINS

Regulatory profile

14 submissions 12 cleared

86% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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