Cleared Traditional

TIELLE HYDROPOLYMER FOAM DRESSING (K964016) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K964016 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device
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Dec 1996
Decision
85d
Days
Class 1
Risk

K964016 is an FDA 510(k) clearance for the TIELLE HYDROPOLYMER FOAM DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on December 31, 1996 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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 Medical, Inc. devices

Submission Details

510(k) Number K964016 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 07, 1996
Decision Date December 31, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 221
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K964016.
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3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
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ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998