Cleared Traditional

K923906 - FOLEY INSERTION TRAY

K923906 is the FDA 510(k) clearance for FOLEY INSERTION TRAY by Kit Pak, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K923906 · Kit Pak, Inc. · Gastroenterology & Urology device
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Jun 1993
Decision
322d
Days
Class 2
Risk

K923906 is an FDA 510(k) clearance for the FOLEY INSERTION TRAY. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 K923906 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 04, 1992
Decision Date June 22, 1993
Days to Decision 322 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
192d slower than avg
Panel avg: 130d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 70
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K923906.
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
PERCUTANEOUS DRAINAGE LOOP CATHETER SET
K931195 · Cook Urological, Inc. · Dec 1993
ONIK-COHEN ACCESS SET
K930608 · Cook Urological, Inc. · Jul 1993
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
RADIFOCUS GUIDE WIRE M
K923607 · Terumo Medical Corp. · Oct 1992
NAUDE URETHRAL STENT
K912851 · Cook Urological, Inc. · Jan 1992