OSM-1 Oxygen Saturation Monitor
510(k) K853331
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853331 | Date14 Jan 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2780
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The OSM-1 Oxygen Saturation Monitor is a photoelectric plethysmograph designed to measure and display oxygen saturation levels in blood. It operates by detecting changes in light absorption through pulsatile blood flow, providing real-time monitoring of arterial oxygen saturation (SpO₂) in clinical settings. This device is classified as a Class II medical device under FDA regulations and falls under the category of cardiovascular monitoring equipment. Its primary function is to assist healthcare providers in assessing a patient’s oxygenation status, particularly in critical care, anesthesia, and respiratory care environments.
The OSM-1 is supplied as a reusable medical device and is intended for use in controlled clinical environments such as hospitals, operating rooms, and intensive care units. It requires proper calibration and maintenance to ensure accurate readings. The device is regulated under FDA 510(k) clearance (K853331) and adheres to the regulatory standards outlined in 21 CFR 870.2780. No specific sterility requirements are noted in the data, but standard infection control protocols should be followed during use. The device’s design and functionality are documented in the FDA submission as substantially equivalent to predicate devices, ensuring compliance with established safety and performance criteria.
Other devices from Criticare Systems, Inc.
Questions
AI-generated answers, 1 Oct 2026
What clinical environments is the OSM-1 Oxygen Saturation Monitor designed for?
The OSM-1 is specifically engineered for controlled clinical settings such as hospitals, operating rooms, and intensive care units. Its primary purpose is to provide real-time monitoring of arterial oxygen saturation (SpO₂) in patients, which is critical in environments where precise oxygenation assessment is essential, such as during anesthesia administration or respiratory care interventions.
Is the OSM-1 Oxygen Saturation Monitor a single-use or reusable device?
The OSM-1 is classified as a reusable medical device. While it is not explicitly marked as sterile, standard infection control protocols must be followed during use to ensure patient safety. Reusability requires proper calibration and maintenance to guarantee accurate and reliable performance over multiple uses.
What regulatory approval does the OSM-1 Oxygen Saturation Monitor hold?
The OSM-1 Oxygen Saturation Monitor holds FDA 510(k) clearance under the reference number K853331. This clearance confirms that the device is substantially equivalent to predicate devices in terms of safety and performance, adhering to regulatory standards outlined in 21 CFR 870.2780. The device is categorized under cardiovascular monitoring equipment and falls under Class II medical device classification.
How does the OSM-1 Oxygen Saturation Monitor measure oxygen saturation?
The OSM-1 uses photoelectric plethysmography to measure oxygen saturation. This method detects changes in light absorption through pulsatile blood flow, allowing it to provide real-time monitoring of arterial oxygen saturation (SpO₂). The device relies on this optical technology to deliver accurate readings, making it suitable for clinical applications where continuous oxygenation assessment is necessary.
What maintenance is required to ensure accurate readings from the OSM-1?
The OSM-1 requires proper calibration and routine maintenance to ensure accurate and reliable performance. Since it is a reusable device, adherence to manufacturer guidelines for cleaning, inspection, and recalibration is essential. Regular maintenance helps sustain the device’s functionality and ensures that it continues to provide dependable oxygen saturation measurements in clinical settings.