Oxygen Monitor No. OM-100, Oxygen Probe No. OP-100

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K860106 ↗

FDA Product Code

CCE

Device Class

Class II

Regulation

21 CFR Part 868.1200

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the OM-100 Oxygen Monitor used for?

  The OM-100 Oxygen Monitor is a Blood-Phase, Indwelling Oxygen Analyzer designed to measure the partial pressure of oxygen (PaO₂) in arterial blood. It provides continuous monitoring of oxygen saturation levels, which is critical for assessing respiratory and circulatory status during anesthesia and intensive care procedures. This real-time data helps clinicians make informed decisions in high-stakes environments like operating rooms and ICUs.

• How is the OM-100 Oxygen Monitor supplied, and what is the role of the OP-100 probe?

  The OM-100 is supplied as a reusable monitor unit, while the OP-100 is a single-use disposable probe. The probe is paired with the monitor for direct arterial blood sampling, ensuring accurate and continuous measurement of PaO₂. Using disposable probes reduces the risk of cross-contamination and maintains hygiene standards in clinical settings.

• Is the OM-100 Oxygen Monitor sterile, and how should it be handled?

  The OM-100 Oxygen Monitor itself is not described as sterile in the regulatory data, but it is designed for clinical use in controlled environments like operating rooms and ICUs. The single-use OP-100 probes are intended for direct contact with arterial blood, so proper handling—including calibration and adherence to manufacturer instructions—is essential to ensure accurate readings and prevent contamination.

• Can the OM-100 Oxygen Monitor be reused, and what are the implications?

  Yes, the OM-100 Oxygen Monitor is designed as a reusable device, while the OP-100 probes are single-use. Reusing the monitor unit allows for cost efficiency and consistent performance across multiple procedures, provided it is properly calibrated and maintained according to the manufacturer’s guidelines. Single-use probes ensure each measurement is conducted with a fresh, uncontaminated component.

• What regulatory pathway does the OM-100 Oxygen Monitor follow, and what class is it?

  The OM-100 Oxygen Monitor follows the FDA 510(k) clearance pathway, specifically under regulation 21 CFR 868.1200. It is classified as a Class II medical device with a product code of CCE, indicating it poses moderate risk and requires specific manufacturing controls to ensure safety and effectiveness. The device was cleared as substantially equivalent to a predicate device in 1986.