LOTA LifeCare Oxygen/Temperature Analyzer 36-001

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880378 ↗

FDA Product Code

CCL

Device Class

Class II

Regulation

21 CFR Part 868.1720

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Lifecare Services, Inc. →

• What is the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 used for?

  The LOTA LifeCare Oxygen/Temperature Analyzer 36-001 is designed specifically for measuring and monitoring oxygen concentration and temperature in gaseous-phase applications. It is primarily used in clinical settings like operating rooms or anesthesia workstations to provide real-time data, ensuring precise control of oxygen levels during medical procedures. This helps improve patient safety and procedural efficacy by maintaining accurate environmental conditions.

• Is the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 a single-use or reusable device?

  The LOTA LifeCare Oxygen/Temperature Analyzer 36-001 is a reusable device. Since it requires proper calibration and maintenance to ensure accurate readings, it is intended for repeated use in clinical environments. Regular upkeep is essential to maintain its performance and reliability over time.

• Does the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 come with sterility guarantees?

  The available data does not specify any sterility guarantees or requirements for the LOTA LifeCare Oxygen/Temperature Analyzer 36-001. Since it is a reusable device, it is not designed for single-use applications, and sterility is not a primary consideration in its use. Proper cleaning and maintenance protocols should be followed to ensure hygiene and functionality.

• What regulatory approval does the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 hold?

  The LOTA LifeCare Oxygen/Temperature Analyzer 36-001 has received FDA 510(k) clearance under the Substantially Equivalent classification, with the clearance number K880378. This approval categorizes it as a Class II medical device, adhering to regulatory standards for safety and performance in its intended use for monitoring oxygen and temperature in anesthesia applications.

• How should the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 be stored?

  While specific storage instructions are not detailed in the provided data, reusable medical devices like the LOTA LifeCare Oxygen/Temperature Analyzer 36-001 generally require storage in a clean, dry environment to prevent damage or contamination. It should be kept away from direct sunlight, extreme temperatures, and sources of moisture. Follow manufacturer guidelines for calibration and maintenance to ensure optimal performance and longevity.