Cleared Traditional

K946269 - CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS

K946269 is an FDA 510(k) clearance for CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC..., manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K946269 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
20d
Days
Class 1
Risk

K946269 is an FDA 510(k) clearance for the CURAFOAM ANDD CURAFOAM PLUS HYDROPHILIC POLYURETHANE FOAM DRESSINGS. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 20 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K946269

510(k) Number K946269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date January 12, 1995
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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 183
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K946269.
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
CUTINOVA THIN WOUND DRESSING
K944581 · Beiersdorf, Inc. · Dec 1994
KERLIX ZINC SALINE DRESSING
K944468 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
DERMAGRAN HYDROPHILIC OINTMENT
K944491 · Derma Sciences, Inc. · Nov 1994