Oxygen Analyzer, Model M25RA & M25RAD

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

Full name

Analyzer, Oxygen Model M25RA & M25RAD

510(k) Number

K782062 ↗

FDA Product Code

CCL

Device Class

Class II

Regulation

21 CFR Part 868.1720

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Miniox IV Portable Pulse Oximeter

  Class II

  FDA 510(k) K874132 Active Cleared 19 Jan 1988

• Model M25RL, (Crc) Oxygen Analyzer

  Class II

  FDA 510(k) K790785 Active Cleared 27 Apr 1979

• Miniox 100 Pulse Oximeter

  Class II

  FDA 510(k) K862798 Active Cleared 28 Aug 1986

• Minico

  Class II

  FDA 510(k) K781746 Active Cleared 5 Dec 1978

• Miniox V Pulse Oximeter

  Class II

  FDA 510(k) K905310 Active Cleared 28 May 1991

• Model M25R, Oxygen Analyzer

  Class II

  FDA 510(k) K790784 Active Cleared 27 Apr 1979

See all devices from Catalyst Research Corp. →

• What is the Oxygen Analyzer, Model M25RA & M25RAD used for?

  The Oxygen Analyzer, Model M25RA & M25RAD, is designed to measure oxygen concentration in gaseous mixtures. It is specifically intended for use in clinical and research environments where accurate oxygen monitoring is essential, particularly in anesthesiology applications such as operating rooms. This ensures precise control of oxygen levels during procedures where patient safety depends on consistent and reliable measurements.

• How is the Oxygen Analyzer, Model M25RA & M25RAD supplied?

  The Oxygen Analyzer, Model M25RA & M25RAD, is supplied as a reusable medical instrument. Unlike single-use devices, it is built for repeated use in clinical and research settings, allowing for consistent performance over time with proper maintenance and calibration. This design supports long-term reliability in environments where oxygen monitoring is critical.

• Is the Oxygen Analyzer, Model M25RA & M25RAD sterile?

  The device is not described as sterile in its specifications. Since it is a reusable instrument, it is intended to be cleaned, maintained, and calibrated between uses. Sterilization procedures would need to be followed as per clinical protocols to ensure safety and functionality for repeated use in patient care or research settings.

• What are the key differences between the M25RA and M25RAD models?

  The provided data does not specify explicit differences between the M25RA and M25RAD models beyond their classification as part of the same analyzer series. Both models are designed for measuring oxygen concentration in gaseous mixtures and are intended for use in clinical and research settings, particularly in anesthesiology. For precise distinctions, such as technical specifications or features, refer to the manufacturer’s documentation or contact Catalyst Research Corp.

• What regulatory approval does the Oxygen Analyzer, Model M25RA & M25RAD, hold?

  The Oxygen Analyzer, Model M25RA & M25RAD, has received FDA 510(k) clearance under the traditional pathway, classified as Class II. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed device and is authorized for distribution in the United States. The device is specifically associated with the Anesthesiology advisory committee and falls under product code CCL.