Cleared Traditional

K941149 - DERMAASSIST HYDROCOLLOID DRESSING

K941149 · Wilshire Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
71d
Days
-
Risk

K941149 is an FDA 510(k) clearance for the DERMAASSIST HYDROCOLLOID DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Wilshire Medical Products (Dallas, US). The FDA issued a Cleared decision on May 20, 1994 after a review of 71 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 - K941149

510(k) Number K941149 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 10, 1994
Decision Date May 20, 1994
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 K941149.
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