510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912374Substantially Equivalent

Bard(r) Urotack(r) 210 Monitoring System

C.R. Bard Inc, Covington GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912374 is the FDA 510(k) clearance record for BARD(R) UROTACK(R) 210 MONITORING SYSTEM, a class II device, cleared for C.R. Bard, Inc. on under FDA product code KOC (Accessories, Blood Circuit, Hemodialysis). FDA records list 646 510(k) clearances for C.R. Bard, Inc., from to . As of , FDA records show no recalls naming K912374.

Clearance record

Decision date
Received
(307 days to decision)
Product code
KOC Accessories, Blood Circuit, Hemodialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
C.R. Bard, Inc. 8195 Industrial Blvd., Covington GA
510(k) summary
Statement
Third party review
No

Clearances, product code KOC

Trailing 12 months

FDA records hold no clearances under product code KOC in the trailing twelve months.

FDA records show no clearances under product code KOC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260