Cleared Traditional

K932310 - KIT PAK INCONTINENT SKIN CARE KIT (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K932310 · Kit Pak, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
386d
Days
Class 1
Risk

K932310 is an FDA 510(k) clearance for the KIT PAK INCONTINENT SKIN CARE KIT. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on June 1, 1994 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5920 - the FDA gastroenterology and urology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kit Pak, Inc. devices

Submission Details

510(k) Number K932310 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 11, 1993
Decision Date June 01, 1994
Days to Decision 386 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 130d · This submission: 386d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYQ Garment, Protective, For Incontinence
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5920
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.