Cleared Traditional

K904852 - DUODERM DRESSINGS

K904852 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Jan 1991
Decision
88d
Days
-
Risk

K904852 is an FDA 510(k) clearance for the DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 88 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K904852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date January 25, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K904852.
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989