510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020967Substantially Equivalent

Terumo Khuri Myocardial Ph Monitoring System

Terumo Cardiovascular Systems Corporation, Tistin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020967 is the FDA 510(k) clearance record for TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, a class II device, cleared for Terumo Cardiovascular Systems Corp. on under FDA product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling). FDA records list 160 510(k) clearances for Terumo Cardiovascular Systems Corp., from to . As of , FDA records show one recall naming K020967.

Clearance record

Decision date
Received
(87 days to decision)
Product code
CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Regulation
21 CFR 868.1170
Device class
Class II
Review panel
Anesthesiology
Applicant
Terumo Cardiovascular Systems Corp. 1311 Valencia Ave., Tistin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBZ

Trailing 12 months

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

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