Cleared Traditional

K941499 - KIT PAK DRESSING CHANGE TRAY (FDA 510(k) Clearance)

Class I General Hospital device.

K941499 · Kit Pak, Inc. · General Hospital
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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

Submission Details

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
15d faster than avg
Panel avg: 128d · This submission: 113d
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.