Cleared Traditional

K943636 - CURADERM ALGINATE HYDROCOLLOID

K943636 is an FDA 510(k) clearance for CURADERM ALGINATE HYDROCOLLOID, 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 68-day FDA review.

K943636 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
68d
Days
Class 1
Risk

K943636 is an FDA 510(k) clearance for the CURADERM ALGINATE HYDROCOLLOID. 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 October 3, 1994 after a review of 68 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 - K943636

510(k) Number K943636 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 27, 1994
Decision Date October 03, 1994
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
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 K943636.
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
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · Smith & Nephew United, Inc. · Aug 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