Cleared Traditional

K954740 - DERMAGRAN WOUND DRESSING

K954740 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
17d
Days
-
Risk

K954740 is an FDA 510(k) clearance for the DERMAGRAN WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

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.

View all Derma Sciences, Inc. devices

FDA 510(k) Submission Details - K954740

510(k) Number K954740 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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 263
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K954740.
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996
TECNOL SALINE WET DRESSING
K954243 · Tecnol Medical Products, Inc. · Nov 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WET DRESSING (ZINC-SALINE)
K954742 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WOUND DRESSING CLEANER W/ZINC
K954743 · Derma Sciences, Inc. · Nov 1995
RECLOSABLE WOUND COVER
K954621 · Hollister, Inc. · Oct 1995