Cleared Traditional

K973619 - KENDALL CURITY NON-ADHERING DRESSING

K973619 is an FDA 510(k) clearance for KENDALL CURITY NON-ADHERING DRESSING, 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 78-day FDA review.

K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
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Dec 1997
Decision
78d
Days
Class 1
Risk

K973619 is an FDA 510(k) clearance for the KENDALL CURITY NON-ADHERING DRESSING. 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 December 10, 1997 after a review of 78 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 - K973619

510(k) Number K973619 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 23, 1997
Decision Date December 10, 1997
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 91
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K973619.
NON-WOVEN COMPRESS
K980382 · Convatec, A Division of E.R. Squibb & Sons · Mar 1998
NONWOVEN DRESSING
K974823 · Convatec, A Division of E.R. Squibb & Sons · Feb 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K974205 · Convatec, A Division of E.R. Squibb & Sons · Feb 1998
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997