Cleared Traditional

K925001 - CURITY CALCIUM ALGINATE WOUND DRESSING

K925001 is an FDA 510(k) clearance for CURITY CALCIUM ALGINATE WOUND 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 101-day FDA review.

K925001 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
101d
Days
Class 1
Risk

K925001 is an FDA 510(k) clearance for the CURITY 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 January 11, 1993 after a review of 101 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 - K925001

510(k) Number K925001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 11, 1993
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
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 K925001.
3M TEGASORB THIN HYDROCOLLOID DRESSING
K924280 · 3M Health Care, Ltd. · May 1993
NASAL CAVITY WOUND DRESSING
K923957 · Smith & Nephew Richards, Inc. · May 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · Coloplast A/S · Mar 1993
ATRAUM WOUND DRESSING--MODIFICATION
K922760 · Axiom Medical, Inc. · Oct 1992
COMFEEL WOUND DRESSING ORD
K922461 · Coloplast A/S · Aug 1992
COMFEEL WOUND DRESSING SD
K922466 · Coloplast A/S · Aug 1992