Oxymax

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

510(k) Number

K895791 ↗

FDA Product Code

BZL

Device Class

Class II

Regulation

21 CFR Part 868.1730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Iso-Thermex

  Class II

  FDA 510(k) K861100 Active Cleared 12 May 1986

• Tremor Monitor

  Class II

  FDA 510(k) K782036 Active Cleared 23 Jan 1979

• Cardiomax-II

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  FDA 510(k) K861543 Active Cleared 10 Mar 1987

• Cardiotherm-500X

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  FDA 510(k) K771718 Active Cleared 28 Sep 1977

• What types of physiological measurements can the Oxymax device provide in laboratory animal studies?

  The Oxymax is designed to measure oxygen consumption and metabolic parameters in laboratory animals, enabling indirect calorimetry. This allows researchers to assess physiological function and energy expenditure under controlled conditions.

• Is the Oxymax device intended for use in sterile environments, or is it meant for non-sterile laboratory settings?

  The Oxymax is explicitly supplied as a reusable research instrument intended for use in non-sterile laboratory environments. It is not designed for sterile applications or MRI-compatible settings.

• What regulatory pathway was followed for FDA clearance of the Oxymax, and which advisory committee was involved?

  The Oxymax received FDA clearance through a Traditional 510(k) review under the Anesthesiology (AN) Advisory Committee. The clearance number is K895791, and it was classified as substantially equivalent to a predicate device.

• How is the Oxymax device categorized under FDA regulations, and what is its primary intended use classification?

  The Oxymax is classified as a Class II medical device under FDA regulation 868.1730, which covers computers used for measuring oxygen uptake. Its primary intended use is for research purposes in controlled laboratory settings to evaluate metabolic function in animals.

• Does the Oxymax come in multiple models or sizes, and how would one determine compatibility for specific research needs?

  The Oxymax is supplied as a single reusable research instrument without explicit mention of multiple models or sizes in the provided data. Compatibility for specific research needs would depend on the manufacturer’s technical specifications, which may include chamber sizes or software configurations for different animal models. Contacting Columbus Instruments would clarify exact model variations.