Cleared Traditional

K941005 - DERMASSIST(TM) XEROFORM PETROLATUM DRESSING

K941005 · Wilshire Medical Products · General & Plastic Surgery device
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Apr 1994
Decision
44d
Days
-
Risk

K941005 is an FDA 510(k) clearance for the DERMASSIST(TM) XEROFORM PETROLATUM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Wilshire Medical Products (Dallas, US). The FDA issued a Cleared decision on April 14, 1994 after a review of 44 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 Wilshire Medical Products devices

FDA 510(k) Submission Details - K941005

510(k) Number K941005 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 01, 1994
Decision Date April 14, 1994
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
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 587
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K941005.
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · Polymedica Industries, Inc. · Dec 1993
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993