Cleared Traditional

DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302) - FDA 510(k) Clearance

K992302 · Dermaphylyx, Inc. · General & Plastic Surgery device
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Sep 1999
Decision
68d
Days
-
Risk

K992302 is an FDA 510(k) clearance for the DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Dermaphylyx, Inc. (Arvada, US). The FDA issued a Cleared decision on September 14, 1999 after a review of 68 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 K992302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1999
Decision Date September 14, 1999
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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