Cleared Traditional

K946245 - TIELLE* HYDROPOLYMER DRESSING

K946245 is an FDA 510(k) clearance for TIELLE* HYDROPOLYMER DRESSING, manufactured by Johnson & Johnson International. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K946245 · Johnson & Johnson International · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
110d
Days
Class 1
Risk

K946245 is an FDA 510(k) clearance for the TIELLE* HYDROPOLYMER DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Johnson & Johnson International (Arlington, US). The FDA issued a Cleared decision on April 11, 1995 after a review of 110 days - within the typical 510(k) review window.

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: 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 International devices

FDA 510(k) Submission Details - K946245

510(k) Number K946245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date April 11, 1995
Days to Decision 110 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 137
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K946245.
CUTINOVA CAVITY
K952526 · Beiersdorf, Inc. · Aug 1995
SPYROFOAM WOUND DRESSING
K951730 · Polymedica Industries, Inc. · Jun 1995
DERMAGRAN HYDROPHILIC OINTMENT
K951499 · Derma Sciences, Inc. · Apr 1995
CURASORB ZN ALGINATE WOUND DRESSING
K950775 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1995
DERMAGRAN WOUND CLEANSER WITH ZINC
K945802 · Derma Sciences, Inc. · Feb 1995
ALLEVYN ADHESIVE
K945330 · Smith & Nephew United, Inc. · Feb 1995