Cleared Traditional

K954235 - HOLLISTER HYDROCOLLOID WOUND DRESSING

K954235 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
25d
Days
-
Risk

K954235 is an FDA 510(k) clearance for the HOLLISTER HYDROCOLLOID WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 25 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K954235

510(k) Number K954235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date October 06, 1995
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K954235.
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RECLOSABLE WOUND COVER
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K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
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PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995