Cleared Traditional

K082459 - ACRYDERM ABSORBENT OXYGEN DRESSING

K082459 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K082459

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 607
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NEOSALUS
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