Cleared Traditional

K933689 - MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING

K933689 is an FDA 510(k) clearance for MODIFICATION OF KENDALL CURASORB CALCIU..., 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 137-day FDA review.

K933689 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
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Dec 1993
Decision
137d
Days
Class 1
Risk

K933689 is an FDA 510(k) clearance for the MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND 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 13, 1993 after a review of 137 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K933689

510(k) Number K933689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1993
Decision Date December 13, 1993
Days to Decision 137 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 115d · This submission: 137d
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 K933689.
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
CHEMOSITE IMPLANTABLE DRUG DELIVERY
K930632 · Device Labs, Inc. · Dec 1993
MESALT STERILE DRESSING
K934839 · Richard Hamer Assoc., Inc. · Dec 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993