Cleared Traditional

K852545 - BAND-AID BRAND ADHESIVE BANDAGES

K852545 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device

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Sep 1985

Decision

83d

Days

Risk

K852545 is an FDA 510(k) clearance for the BAND-AID BRAND ADHESIVE BANDAGES. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 83 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number	K852545 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	June 14, 1985
Decision Date	September 05, 1985
Days to Decision	83 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

32d faster than avg

Panel avg: 115d · This submission: 83d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 225

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K852545.

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

ATRAUM WOUND DRESSING

K852614 · Axiom Medical, Inc. · Aug 1985

CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE

K850147 · Beiersdorf, Inc. · Jul 1985

BARD OCCLUSIVE WOUND DRESSING

K850889 · C.R. Bard, Inc. · Jul 1985

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K852545

Johnson & Johnson Professionals, Inc.

Raynham, MA · US

OMEGA NORTON-CRABLE

Regulatory profile

206 submissions 184 cleared

89% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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