Cleared Traditional

K861384 - NON-ADHERING DRESSING WITH POVIDONE-IODINE

K861384 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Jul 1986
Decision
78d
Days
-
Risk

K861384 is an FDA 510(k) clearance for the NON-ADHERING DRESSING WITH POVIDONE-IODINE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 78 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 K861384 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 14, 1986
Decision Date July 01, 1986
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 K861384.
HYDROCOLLOID DRESSINGS - STERILE
K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986
HOLLISTER WOUND CARE BARRIER
K862572 · Hollister, Inc. · Aug 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · Johnson & Johnson Professionals, Inc. · Jul 1986
BARD ABSORPTION DRESSING
K861024 · C.R. Bard, Inc. · Apr 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