Cleared Traditional

K940738 - KTI HY-Q(TM) WOUND DRESSING

K940738 is an FDA 510(k) clearance for KTI HY-Q(TM) WOUND DRESSING, manufactured by Kingston Technologies, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K940738 · Kingston Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
78d
Days
Class 1
Risk

K940738 is an FDA 510(k) clearance for the KTI HY-Q(TM) WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Kingston Technologies, Inc. (Dayton, US). The FDA issued a Cleared decision on May 6, 1994 after a review of 78 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 Kingston Technologies, Inc. devices

FDA 510(k) Submission Details - K940738

510(k) Number K940738 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 17, 1994
Decision Date May 06, 1994
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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 75
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K940738.
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
CURASALT HYPERTONIC SALINE DRESSING
K942459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993