Cleared Traditional

K901853 - MODIFIED LABELING FOR BIOCLUSIVE* TRANS...

K901853 is the FDA 510(k) clearance for MODIFIED LABELING FOR BIOCLUSIVE* TRANS... by Johnson & Johnson Medical, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAD) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K901853 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device
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Jan 1991
Decision
279d
Days
Class 1
Risk

K901853 is an FDA 510(k) clearance for the MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 279 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - the FDA general and plastic surgery device framework. 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 Medical, Inc. devices

Submission Details

510(k) Number K901853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date January 28, 1991
Days to Decision 279 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
164d slower than avg
Panel avg: 115d · This submission: 279d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NAD Dressing, Wound, Occlusive

All 26
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K901853.
WET CHAMBER
K020781 · Kinetic Concepts, Inc. · May 2002
MEDLINE STERILE GAUZE SPONGES
K930697 · Medline Industries, Inc. · Jun 1993
TENSOPLUS LITE
K901378 · Smith & Nephew United, Inc. · Jun 1990
HYPAFIX DRESSING RETENTION SHEET
K894254 · Smith & Nephew United, Inc. · Aug 1989
DUODERM* TRANSPARENT HYDROCOLLOID DRESSING-MODIFY
K892527 · Convatec, A Division of E.R. Squibb & Sons · May 1989
DUODERM* EXTRA THIN FLEXIBLE HYDROCOLLOID DRESSING
K891696 · Convatec, A Division of E.R. Squibb & Sons · May 1989