Cleared Traditional

DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875) - FDA 510(k) Clearance

K990875 · Dermaphylyx, Inc. · General & Plastic Surgery device
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May 1999
Decision
72d
Days
-
Risk

K990875 is an FDA 510(k) clearance for the DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Dermaphylyx, Inc. (Arvada, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 72 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 Dermaphylyx, Inc. devices

Submission Details

510(k) Number K990875 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 16, 1999
Decision Date May 27, 1999
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -