Cleared Traditional

K912374 - BARD(R) UROTACK(R) 210 MONITORING SYSTEM

K912374 is an FDA 510(k) clearance for BARD UROTACK 210 MONITORING SYSTEM, 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 307-day FDA review.

K912374 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
307d
Days
Class 2
Risk

K912374 is an FDA 510(k) clearance for the BARD(R) UROTACK(R) 210 MONITORING SYSTEM. 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 31, 1992 after a review of 307 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: 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.

FDA 510(k) Submission Details - K912374

510(k) Number K912374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1991
Decision Date March 31, 1992
Days to Decision 307 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 131d · This submission: 307d
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 181
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K912374.
RS-1000
K911230 · Cp Medical · Jun 1993
DIGI -FLOW
K920671 · D and D Technology, Inc. · Jan 1993
HEMO-BAND
K920614 · Innovations IN Access, Inc. · Jul 1992
DRAIN/PRIMING/RECIRCULATION BAG
K913361 · Haemotronic, Inc. · Mar 1992
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991
MINNILERT(R) PRESSURE MONITOR
K913483 · Minntech Corp. · Sep 1991
K912374 · BARD(R) UROTACK(R) 210 MONITORING SYSTEM
Download PDF C.R. Bard, Inc.