Cleared Traditional

K924436 - BARD UROTRACK II MONITORING

K924436 is an FDA 510(k) clearance for BARD UROTRACK II MONITORING, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 560-day FDA review.

K924436 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
560d
Days
Class 2
Risk

K924436 is an FDA 510(k) clearance for the BARD UROTRACK II MONITORING. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 15, 1994 after a review of 560 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K924436

510(k) Number K924436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date March 15, 1994
Days to Decision 560 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
429d slower than avg
Panel avg: 131d · This submission: 560d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

Product Code KOC Accessories, Blood Circuit, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 137
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K924436.
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
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DIAL MEDICAL KIT
K941543 · Regulatory & Marketing Services, Inc. · Feb 1995
SILICONE CATHETER REPAIR KITS
K926374 · Akcess Medical Products, Inc. · Oct 1994
RS-1000
K911230 · Cp Medical · Jun 1993
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · C.R. Bard, Inc. · Mar 1992
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991