Cleared Traditional

K943619 - CAVI-CARE CONFORMING FOAM DRESSING

K943619 is an FDA 510(k) clearance for CAVI-CARE CONFORMING FOAM DRESSING, manufactured by Smith & Nephew United, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K943619 · Smith & Nephew United, Inc. · General & Plastic Surgery device
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Aug 1994
Decision
23d
Days
Class 1
Risk

K943619 is an FDA 510(k) clearance for the CAVI-CARE CONFORMING FOAM DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on August 19, 1994 after a review of 23 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 Smith & Nephew United, Inc. devices

FDA 510(k) Submission Details - K943619

510(k) Number K943619 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 27, 1994
Decision Date August 19, 1994
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 147
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K943619.
KERLIX ZINC SALINE DRESSING
K944468 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
DERMAGRAN HYDROPHILIC OINTMENT
K944491 · Derma Sciences, Inc. · Nov 1994
CURADERM ALGINATE HYDROCOLLOID
K943636 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1994
SAF-GEL HYDRATING DERMAL WOUND DRESSING
K942270 · Calgon Vestal Div. · Aug 1994
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · Trinity Laboratories, Inc. · Jun 1994