Respiree

Company overview

Respiree develops wearable monitoring hardware and connected-care software for hospitals and care outside the hospital. Founded in Singapore in 2019, the company established its global headquarters at Houston’s TMC Innovation. Founder and CEO Gurpreet Singh leads the business.

Its offering combines the Respiree Cardio-Respiratory Monitor System with connectivity, dashboards and analytics. The company markets connected-care services under RespireeCare and 1Bio, and its software is listed on Roche’s navify marketplace.

The U.S. device clearance is specifically for non-invasive spot checking of respiration rate in adults. That authorized use is narrower than the company’s broader work in predictive analytics and connected patient monitoring, which should be assessed separately from the monitor’s cleared indication.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared the Respiree Cardio-Respiratory Monitor under K223681 in March 2023 and the updated Cardio-Respiratory Monitor System under K250934 in August 2025. The latter is a Class II respiratory monitor for non-invasive spot checking of respiration rate in adult patients, in hospital and hospital-type non-ICU settings and at home. ^[2][3]

The device is not intended for critical-care patients. The clearance does not establish authorization for every predictive model, continuous surveillance feature or broader cardiorespiratory claim associated with Respiree’s software ecosystem. ^[3][7]

Regulatory snapshot How to read this snapshot

U.S. FDA

2+

510(k) clearances

—

De Novo grants

—

PMA approvals

—

Recall events

Latest recorded source review: 2026-11-04.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Wearable respiratory monitor

Respiree Cardio-Respiratory Monitor System ↗

Connected wearable monitor for non-invasive spot checking of adult respiration rate. The hardware connects with Respiree’s software and care-management ecosystem; predictive analytics are distinct from its cleared respiratory-rate indication. ^[7][3][2]

FDA-cleared respiration-rate monitoring