Cleared Traditional

JOHNSON & JOHNSON ADHESIVE FILM DRESSING (K810053) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K810053 · Johnson & Johnson Professionals, Inc. · General & Plastic Surgery device
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Jan 1981
Decision
16d
Days
Class 1
Risk

K810053 is an FDA 510(k) clearance for the JOHNSON & JOHNSON ADHESIVE FILM DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: 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 K810053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1981
Decision Date January 28, 1981
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 19
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K810053.
TEGADERM TRANSPARENT DRESSING
K811291 · 3M Company · Jun 1981
BAND-AID KITCHEN ASSORTMENT
K810623 · Johnson & Johnson Professionals, Inc. · Mar 1981
SCOTCH BRAND ADHESIVE TAPE
K810580 · 3M Company · Mar 1981
3M HI-STRENGTH MED. TAPE #1534
K802242 · 3M Company · Sep 1980
ELASTIC ADHESIVE BANDAGES(STERILE)
K801794 · Smith & Nephew, Inc. · Aug 1980
TAPE, DERMICEL, CLOTH
K770362 · Johnson & Johnson Professionals, Inc. · Jun 1977