Criticare Systems, Inc. - FDA 510(k) Cleared Devices

Criticare Systems, Inc. is an international medical device company headquartered in Warwick, RI, with a manufacturing facility in Milwaukee, US. The company develops and distributes patient monitoring devices and anesthetic gas monitoring systems. Products address safety and monitoring needs in anesthesia, critical care, respiratory care, transport, and outpatient care environments.

Criticare Systems received 22 FDA 510(k) clearances from 22 total submissions between 1986 and 2010. The company's cleared devices focus on cardiovascular monitoring, including vital signs monitors, patient monitors, and telemetry systems. The company is currently inactive, with no clearances recorded in more than 13 years, and should be treated as a historical regulatory record.

Notable innovations include ComfortCuff® NIBP technology, DOX™ Digital Oximetry, and the first hospital-grade ambulatory telemetry monitor transmitting real-time ECG, NIBP, and SpO2 data simultaneously. The company pioneered handheld pulse oximetry and combined pulse oximetry with capnography in integrated systems.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database.