Cleared Traditional

EMPI TAPE PATCHES (K941389) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K941389 · Empi · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
154d
Days
Class 1
Risk

K941389 is an FDA 510(k) clearance for the EMPI TAPE PATCHES. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on August 23, 1994 after a review of 154 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 Empi devices

Submission Details

510(k) Number K941389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1994
Decision Date August 23, 1994
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 186
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K941389.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH
K915358 · Medtronic Vascular · Apr 1992
3M FIRST AID BANDAGE FOR MINOR WOUNDS
K901777 · 3M Company · Aug 1990
TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
K901845 · 3M Company · Jul 1990
DERMASTRIP
K883660 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984