Cleared Traditional

J & J ULCER DRESSING (K850451) - FDA 510(k) Clearance

K850451 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
119d
Days
-
Risk

K850451 is an FDA 510(k) clearance for the J & J ULCER DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 119 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K850451 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 06, 1985
Decision Date June 05, 1985
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K850451.
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982
TEGADERM TRANSPARENT DRESSING
K812678 · 3M Company · Jan 1982