SENSOMAT

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K771722 ↗

FDA Product Code

CCC

Device Class

Class II

Regulation

21 CFR Part 868.1150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Biochem Model 3301 NEWOX1 Oximeter

  Class II

  FDA 510(k) K920082 Active Cleared 7 Jan 1993

• Biochem Co/Ox 1000

  Class II

  FDA 510(k) K863186 Active Cleared 7 Nov 1986

• Micro Span Transcutaneous Oxygen Monit

  Class II

  FDA 510(k) K840918 Active Cleared 17 Apr 1984

• Sensomat

  Class II

  FDA 510(k) K803014 Active Cleared 22 Dec 1980

• Biochem 515 Respiration Monitor

  Class II

  FDA 510(k) K854333 Active Cleared 30 May 1986

• Biochem 8090 Capnograph Open recall

  Class II

  FDA 510(k) K871133 Active Cleared 21 Apr 1987

See all devices from Biochem International, Inc. →

• What clinical settings is the SENSOMAT intended for use in, and how does it support patient monitoring during those procedures?

  The SENSOMAT is designed for use in clinical settings like operating rooms and critical care units, where real-time monitoring of respiratory gas exchange is essential. It measures the partial pressure of carbon dioxide (PCO₂) in arterial or venous blood, providing critical data during anesthesia and intensive care procedures to ensure proper ventilation and oxygenation of patients.

• Is the SENSOMAT a single-use or reusable device, and what does this mean for maintenance and cost considerations?

  The SENSOMAT is a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This design can reduce per-procedure costs compared to single-use alternatives, though it requires adherence to facility protocols for reprocessing and sterilization to ensure safety and performance.

• What regulatory pathway was followed for the SENSOMAT’s FDA clearance, and how does this classification impact its use?

  The SENSOMAT was cleared through the FDA’s 510(k) pathway, specifically under Traditional review (K771722, K803014), and is classified as a Class 2 device. This classification means it is subject to general controls and special controls for blood gas analyzers, ensuring it meets performance standards for measuring PCO₂ in clinical settings like anesthesia and intensive care.

• Are there specific storage requirements for the SENSOMAT, and how should it be handled to maintain accuracy and reliability?

  The provided data does not specify storage requirements for the SENSOMAT, but as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling, including regular calibration and maintenance, is critical to ensure accurate PCO₂ measurements during patient monitoring.