Cleared Traditional

K914733 - TTL MEDICATED DRESSING

K914733 is an FDA 510(k) clearance for TTL MEDICATED DRESSING, manufactured by Medimix Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K914733 · Medimix Products, Inc. · General & Plastic Surgery device
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Jul 1992
Decision
254d
Days
Class 1
Risk

K914733 is an FDA 510(k) clearance for the TTL MEDICATED DRESSING. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Medimix Products, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 1, 1992 after a review of 254 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Medimix Products, Inc. devices

FDA 510(k) Submission Details - K914733

510(k) Number K914733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1991
Decision Date July 01, 1992
Days to Decision 254 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 115d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 90
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K914733.
DUODERM SUSTAINED COMPRESSION BANDAGE
K920675 · Convatec, A Division of E.R. Squibb & Sons · Aug 1992
ACRYLASTIC
K921759 · Beiersdorf, Inc. · Aug 1992
TRICOPLAST
K921760 · Beiersdorf, Inc. · Aug 1992
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
CANN-HOLD
K915057 · O.R. Concepts, Inc. · Mar 1992
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K914315 · Medical Dynamics, Inc. · Mar 1992