Cleared Traditional

K941499 - KIT PAK DRESSING CHANGE TRAY

K941499 is an FDA 510(k) clearance for KIT PAK DRESSING CHANGE TRAY, manufactured by Kit Pak, Inc.. The device is a Class 1 General Hospital device with product code KGX cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K941499 · Kit Pak, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
113d
Days
Class 1
Risk

K941499 is an FDA 510(k) clearance for the KIT PAK DRESSING CHANGE TRAY. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5240 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kit Pak, Inc. devices

FDA 510(k) Submission Details - K941499

510(k) Number K941499 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 29, 1994
Decision Date July 20, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 K941499.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
EMPI TAPE PATCHES
K941389 · Empi · Aug 1994
COVERLET ADHESIVE DRESSING
K940378 · Beiersdorf, Inc. · Jul 1994
CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
K935948 · Convatec, A Division of E.R. Squibb & Sons · Mar 1994
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · Deroyal Industries, Inc. · Feb 1994
3M TEGADERM HP TRANSPARENT DRESSING
K932422 · 3M Health Care, Ltd. · Dec 1993