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

FDA 510(k) Submission Details - K954742

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
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 K954742.
TECNOL SALINE WET DRESSING
K954243 · Tecnol Medical Products, Inc. · Nov 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WOUND DRESSING
K954740 · 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
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995