Cleared Traditional

K954738 - DERMAGRAN HYDROPHILIC WOUND DRESSING

K954738 · Derma Sciences, Inc. · General & Plastic Surgery device

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Nov 1995

Decision

17d

Days

Risk

K954738 is an FDA 510(k) clearance for the DERMAGRAN HYDROPHILIC WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Derma Sciences, Inc. (Old Forge, US). The FDA issued a Cleared decision on November 2, 1995 after a review of 17 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.

FDA 510(k) Submission Details - K954738

510(k) Number	K954738 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 16, 1995
Decision Date	November 02, 1995
Days to Decision	17 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

98d faster than avg

Panel avg: 115d · This submission: 17d

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 76

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K954738.

SPYROCOLLOID WOUND DRESSING

K955383 · Polymedica Industries, Inc. · Dec 1995

SPYROFLEX SKIN PROTECTOR

K953885 · Polymedica Industries, Inc. · Nov 1995

FLEXZAN WOUND DRESSING

K954602 · Dow Hickam Pharmaceuticals, Inc. · Nov 1995

TECNOL ISLAND WOUND DRESSING

K954033 · Tecnol Medical Products, Inc. · Sep 1995

UNI-SITE

K953018 · Ttl Medical · Sep 1995

SPYROFLEX WOUND DRESSING

K953618 · Polymedica Industries, Inc. · Aug 1995

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 K954738

Derma Sciences, Inc.

Old Forge, PA · US

HOWARD ENFIEJIAN

Regulatory profile

22 submissions 18 cleared

82% clearance rate · Active in General & Plastic Surgery

View all devices by Derma Sciences, Inc. →

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: November 2, 1995. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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