Cleared Traditional

K954742 - DERMAGRAN WET DRESSING (ZINC-SALINE)

K954742 · Derma Sciences, Inc. · General & Plastic Surgery device
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Nov 1995
Decision
17d
Days
-
Risk

K954742 is an FDA 510(k) clearance for the DERMAGRAN WET DRESSING (ZINC-SALINE). 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

Submission Details

510(k) Number K954742 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
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 189
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K954742.
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632 · Convatec, A Division of E.R. Squibb & Sons · Dec 1997
SIGNALDRESS
K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996
RECLOSABLE WOUND COVER
K954621 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995