510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874605Substantially Equivalent

Hi-Lo Temp(r) Myocardial Temperature Sensor

Mallinckrodt Critical Care, Argyle NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874605 is the FDA 510(k) clearance record for HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR, a class I device, cleared for Mallinckrodt Critical Care on under FDA product code KRI (Accessory Equipment, Cardiopulmonary Bypass). FDA records list 92 510(k) clearances for Mallinckrodt Critical Care, from to . As of , FDA records show no recalls naming K874605.

Clearance record

Decision date
Received
(85 days to decision)
Product code
KRI Accessory Equipment, Cardiopulmonary Bypass
Regulation
21 CFR 870.4200
Device class
Class I
Review panel
Cardiovascular
Applicant
Mallinckrodt Critical Care Hook Rd., Argyle NY
Third party review
No

Clearances, product code KRI

Trailing 12 months

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

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