Cleared Traditional

K983163 - BIATAIN FOAM DRESSING

K983163 · Coloplast Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 1998
Decision
97d
Days
-
Risk

K983163 is an FDA 510(k) clearance for the BIATAIN FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Coloplast Corp. devices

Submission Details

510(k) Number K983163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1998
Decision Date December 16, 1998
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K983163.
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
COMPEED PSORIASIS DRESSING
K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM ADHESIVE DRESSING
K983173 · Coloplast Corp. · Dec 1998
DUODERM CGF CONTROL GEL FORMULA DRESSING
K973632 · Convatec, A Division of E.R. Squibb & Sons · Dec 1997
KENDALL CURITY PETROLATUM GAUZE
K973511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997