Cleared Traditional

K850889 - BARD OCCLUSIVE WOUND DRESSING

K850889 · C.R. Bard, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
123d
Days
-
Risk

K850889 is an FDA 510(k) clearance for the BARD OCCLUSIVE WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 123 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K850889 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 04, 1985
Decision Date July 05, 1985
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 K850889.
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K852750 · 3M Company · Sep 1985
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K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147 · Beiersdorf, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
AQUAPHOR R GAUZE
K842967 · Beiersdorf, Inc. · Nov 1984
COMFEEL ULCUS SHEET
K840438 · Coloplast A/S · Nov 1984