Cleared Traditional

K953781 - INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS

K953781 is an FDA 510(k) clearance for INNOVATIVE TECHNOLOGIES CALCIUM ALGINAT..., manufactured by Innovative Technologies , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K953781 · Innovative Technologies , Ltd. · General & Plastic Surgery device
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Sep 1995
Decision
18d
Days
Class 1
Risk

K953781 is an FDA 510(k) clearance for the INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Innovative Technologies , Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on September 1, 1995 after a review of 18 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 Innovative Technologies , Ltd. devices

FDA 510(k) Submission Details - K953781

510(k) Number K953781 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 14, 1995
Decision Date September 01, 1995
Days to Decision 18 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 115d · This submission: 18d
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 108
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K953781.
COMFEEL:ALGINATE DRESSING
K953497 · Coloplast A/S · Sep 1995
HYDROPHILIC FOAM DRESSING
K953019 · Busse Hospital Disposables, Inc. · Sep 1995
WOUNDFOAM 4 X 4
K953070 · Trinity Laboratories, Inc. · Sep 1995
CUTINOVA CAVITY
K952526 · Beiersdorf, Inc. · Aug 1995
SPYROFOAM WOUND DRESSING
K951730 · Polymedica Industries, Inc. · Jun 1995
DERMAGRAN HYDROPHILIC OINTMENT
K951499 · Derma Sciences, Inc. · Apr 1995