Cleared Traditional

K895207 - BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM

K895207 · Johnson & Johnson International · General & Plastic Surgery device
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Sep 1989
Decision
42d
Days
-
Risk

K895207 is an FDA 510(k) clearance for the BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson International (New Brunswick, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 42 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.

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FDA 510(k) Submission Details - K895207

510(k) Number K895207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1989
Decision Date September 28, 1989
Days to Decision 42 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
73d faster than avg
Panel avg: 115d · This submission: 42d
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 303
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K895207.
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
KALTOCARB WOUND DRESSING
K894347 · Calgon Vestal Div. · Aug 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989
KALTOSTAT WOUND PACKING
K892868 · Calgon Vestal Div. · Jul 1989