510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133658Substantially Equivalent

Cdi Blood Parameter Monitoring System 500

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

K133658 is the FDA 510(k) clearance record for CDI BLOOD PARAMETER MONITORING SYSTEM 500, a class II device, cleared for Terumo Cardiovascular Systems Corp. on under FDA product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass). FDA records list 160 510(k) clearances for Terumo Cardiovascular Systems Corp., from to . As of , FDA records show 4 recalls naming K133658.

Clearance record

Decision date
Received
(240 days to decision)
Product code
DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4330
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Cardiovascular Systems Corp. 6200 Jackson Rd., Ann Arbor MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRY

Trailing 12 months

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

FDA records show no clearances under product code DRY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRY, 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