Cleared Traditional

K904852 - DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK

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.

FDA 510(k) Submission Details - K904852

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.

FRO Device Classification - Class 0,

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 709

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K904852.

ALGINATE FIBER

K905040 · Shepherd Medical Corp. · Aug 1991

NORMLGEL PROTECTIVE WOUND GEL

K905438 · Scott Health Care · Apr 1991

ALGODERM ALGINATE WOUND DRESSING

K905314 · Les Laboratorires Brothier, S.A. · Feb 1991

CARRINGTON WOUND DRESSING

K902345 · Carrington Laboratories, Inc. · Jun 1990

WOUND TREATMENT KIT

K901109 · Orion Life Systems, Inc. · Jun 1990

MESALT STERILE DRESSING

K897142 · Scott Health Care · Mar 1990

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K904852

Convatec, A Division of E.R. Squibb & Sons

Princeton, NJ · US

MARILYN B DREYLING

Regulatory profile

81 submissions 68 cleared

84% clearance rate · Active in General & Plastic Surgery

View all devices by Convatec, A Division of E.R. Squibb & Sons →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 25, 1991. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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