Cleared Traditional

K861024 - BARD ABSORPTION DRESSING

K861024 · C.R. Bard, Inc. · General & Plastic Surgery device
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Apr 1986
Decision
23d
Days
-
Risk

K861024 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. (Murray Hill, US). The FDA issued a Cleared decision on April 10, 1986 after a review of 23 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.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K861024 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 18, 1986
Decision Date April 10, 1986
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 K861024.
HOLLISTER WOUND CARE BARRIER
K862572 · Hollister, Inc. · Aug 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · Johnson & Johnson Professionals, Inc. · Mar 1986
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE
K853844 · Convatec, A Division of E.R. Squibb & Sons · Nov 1985
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 1985