Respiration Monitor Type MR-10

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

510(k) Number

K822077 ↗

FDA Product Code

FLS

Device Class

Class II

Regulation

21 CFR Part 868.2377

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What clinical environments is the Respiration Monitor Type MR-10 primarily designed for, and how does it function in those settings?

  The Respiration Monitor Type MR-10 is specifically designed for facility-based use in critical care environments where real-time respiratory monitoring is essential, such as anesthesia and intensive care units. It continuously assesses and alerts healthcare providers to respiratory pauses (apnea), ensuring timely intervention to maintain patient safety during procedures or prolonged care.

• Is the Respiration Monitor Type MR-10 intended for single-use or reusable applications, and what does this mean for maintenance?

  The Respiration Monitor Type MR-10 is supplied as a reusable medical instrument, meaning it is not disposable. This requires adherence to facility-based cleaning, sterilization, and maintenance protocols to ensure reliable performance and patient safety over repeated uses.

• What regulatory pathway was followed for FDA clearance of the Respiration Monitor Type MR-10, and what does this imply about its compliance?

  The device underwent a traditional 510(k) review process with the FDA, classified as substantially equivalent (SESE) under product code FLS for respiratory monitoring systems. This clearance confirms it meets Class II device standards for apnea detection in anesthesia applications, though specific sterility or MRI safety details are not provided in the available data.

• Are there different models or sizes available for the Respiration Monitor Type MR-10, and how might this affect its application?

  The provided data does not specify multiple models or sizes for the MR-10, indicating it is likely a single-configuration device. Its design is standardized for facility-based use in anesthesia, so variability in sizing or customization is not mentioned. Always verify compatibility with your facility’s specific patient monitoring needs.