Cleared Traditional

K831710 - BARD ABSORPTION DRESSING

K831710 · C.R. Bard, Inc. · General & Plastic Surgery device
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Jan 1984
Decision
221d
Days
-
Risk

K831710 is an FDA 510(k) clearance for the BARD ABSORPTION DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 221 days - an extended review 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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K831710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1983
Decision Date January 03, 1984
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
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 K831710.
COMFEEL ULCUS SHEET
K840438 · Coloplast A/S · Nov 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · Convatec, A Division of E.R. Squibb & Sons · May 1983
CONVERTORS PRIMARY WOUND DRESSING II
K822990 · American Hospital Supply Corp. · Apr 1983
CURITY TRANSPARENT FILM DRESSING
K822424 · The Kendal Co. · Dec 1982