OSC-80 Oximeter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K862161 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Waters Instruments, Inc. →

• What is the OSC-80 Oximeter used for?

  The OSC-80 Oximeter is a non-invasive pulse oximetry device designed to monitor a patient’s arterial oxygen saturation (SpO₂) and pulse rate in real time. Clinicians use it to assess oxygenation status during continuous or intermittent monitoring in settings like operating rooms, intensive care units, or general hospital wards. Its readings help guide clinical decisions, such as ventilator adjustments or anesthesia management, by providing objective data on a patient’s respiratory health.

• Is the OSC-80 Oximeter single-use or reusable?

  The OSC-80 Oximeter is supplied as a reusable medical device. Unlike disposable oximeters, this model is intended for repeated use in clinical environments, provided it undergoes proper calibration, maintenance, and cleaning as specified in its operational manual. Reusability extends its cost-effectiveness for healthcare facilities while ensuring consistent performance over time.

• Does the OSC-80 Oximeter require any special storage conditions?

  The device data does not specify special storage conditions beyond standard environmental requirements for medical electronics. To maintain accuracy and longevity, it should be stored in a clean, dry location away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Follow the manufacturer’s guidelines for powering off and protecting the device during transport or when not in use.

• What regulatory clearance does the OSC-80 Oximeter hold?

  The OSC-80 Oximeter holds FDA 510(k) clearance under the reference number K862161, classified under product code DQA. The clearance was determined by the Cardiovascular Advisory Committee as Substantially Equivalent (SESE) to a predicate device, indicating it meets regulatory standards for safety and effectiveness as a diagnostic oximeter. This classification applies to its intended use in clinical settings for monitoring oxygen saturation and pulse rate.

• How does the OSC-80 Oximeter differ from other reusable oximeters?

  The OSC-80 stands out as a reusable pulse oximeter with a legacy of FDA clearance since 1986, reflecting its long-standing reliability in clinical environments. Unlike newer single-use alternatives, it is designed for durability and repeated calibration, making it suitable for high-volume settings like operating rooms or ICUs where continuous monitoring is critical. Its traditional design also ensures compatibility with legacy systems and sensors, though specific technical differences (e.g., sensor type, display resolution) would require consulting the manufacturer’s specifications.