Cleared Traditional

K992302 - DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS

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

FDA 510(k) Submission Details - K992302

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

47d faster than avg

Panel avg: 115d · This submission: 68d

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 K992302.

FASTSEAL CHEST WOUND DRESSING

K990079 · Greenfield Medical Technologies, Inc. · Dec 1999

SIMPLICARE TRANSPARENT WOUND DRESSING

K991214 · Hollister, Inc. · Oct 1999

GILTECH PLUS TRANSPARENT DRESSING

K992005 · Giltech Plus, Inc. · Sep 1999

DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING

K990875 · Dermaphylyx, Inc. · May 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

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K992302

Dermaphylyx, Inc.

Arvada, CO · US

ANDREW M REED

Regulatory profile

9 submissions 7 cleared

78% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: September 14, 1999. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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