Cleared Traditional

K990875 - DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING

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

FDA 510(k) Submission Details - K990875

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K990875.
SIMPLICARE TRANSPARENT WOUND DRESSING
K991214 · Hollister, Inc. · Oct 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · Dermaphylyx, Inc. · Sep 1999
GILTECH PLUS TRANSPARENT DRESSING
K992005 · Giltech Plus, Inc. · Sep 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
K990438 · Dermaphylyx, Inc. · Mar 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · Molnlycke Health Care, Inc. · Mar 1999
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
K983303 · Innovative Technologies , Ltd. · Dec 1998