Modified Myocardial Temperature Sensor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K874522 ↗

FDA Product Code

KRB

Device Class

Class II

Regulation

21 CFR Part 870.1915

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Mon-A-Therm's Skin Temperature Sensor

  Class II

  FDA 510(k) K875234 Active Cleared 19 Jan 1988

• Modified Airway Temperature Sensor

  Class II

  FDA 510(k) K874520 Active Cleared 6 Jan 1988

• Modified Foley Catheter/Temperature Sensor

  Class II

  FDA 510(k) K874525 Active Cleared 6 Jan 1988

• Modified Esophageal Stethoscope/Temperature Sensor

  Class I

  FDA 510(k) K874519 Active Cleared 29 Jan 1988

• Temperature Trend Indicator (TTI)

  Class II

  FDA 510(k) K820426 Active Cleared 8 Mar 1982

• Modified Tympanic & Esophageal/Rectal Temp. Sensor

  Class II

  FDA 510(k) K874523 Active Cleared 6 Jan 1988

See all devices from Mon-A-Therm, Inc. →

• What is the Modified Myocardial Temperature Sensor used for?

  It is a probe-type thermodilution device used for measuring temperature in cardiovascular applications, specifically designed for cardiovascular monitoring as stated in its intended use.

• How is the Modified Myocardial Temperature Sensor supplied and is it reusable?

  The device data does not specify supply format or reusability; therefore, no information about whether it is single-use or reusable, or how it is packaged, can be derived from the provided details.

• What regulatory pathway was used for the Modified Myocardial Temperature Sensor?

  It received FDA 510(k) clearance (K874522) on January 29, 1988, through a traditional review process, and was found substantially equivalent to a predicate device.