Cleared Traditional

K914596 - SURGICAL CLOTH TAPE (HEALRITE)

K914596 is an FDA 510(k) clearance for SURGICAL CLOTH TAPE (HEALRITE), manufactured by Industrias Tuk, S.A. DE C.V.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K914596 · Industrias Tuk, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
155d
Days
Class 1
Risk

K914596 is an FDA 510(k) clearance for the SURGICAL CLOTH TAPE (HEALRITE). Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Industrias Tuk, S.A. DE C.V. (N.L., Mexico, MX). The FDA issued a Cleared decision on March 19, 1992 after a review of 155 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 Industrias Tuk, S.A. DE C.V. devices

FDA 510(k) Submission Details - K914596

510(k) Number K914596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date March 19, 1992
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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 91
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K914596.
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
CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE
K912518 · Convatec, A Division of E.R. Squibb & Sons · Sep 1991