Cleared Traditional

K881050 - DUODERM(R) CGF

K881050 is an FDA 510(k) clearance for DUODERM CGF, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K881050 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
21d
Days
Class 1
Risk

K881050 is an FDA 510(k) clearance for the DUODERM(R) CGF. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. 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 - K881050

510(k) Number K881050 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 11, 1988
Decision Date April 01, 1988
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 107
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K881050.
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
BFGOODRICH BIOTHANE NON-ADHERENT DRESSING
K875253 · The Bfgoodrich Co. · Apr 1988
POLYDERM A+B(TM)
K880153 · Laivan Corp. · Apr 1988
ENVICLUSIVE (TM)
K874554 · Marion Laboratories, Inc. · Mar 1988
POLYDERM WBC (TM), WATERPROOF BREATHABLE COVER
K880206 · Laivan Corp. · Mar 1988
PHARMACLUSIVE (TM)
K872573 · Pharmacia, Inc. · Feb 1988
K881050 · DUODERM(R) CGF
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