Clearo

Clearo is a mechanical insufflation-exsufflation (MI-E) airway clearance device that delivers positive pressure air to a patient's airways, then rapidly shifts to negative pressure to stimulate a natural cough. It is indicated for adult and pediatric patients unable to cough or clear secretions effectively, and can be used with a facemask, mouthpiece, or endotracheal/tracheostomy tube in hospital, institutional, or home settings.

Clearo uses a blower, solenoid-controlled valve, and microcontroller electronics to deliver insufflation pressures from 3–70 cmH2O and exsufflation pressures from −3 to −70 cmH2O, with optional oscillatory vibrations (1–20 Hz, up to 10 cmH2O amplitude). It offers Manual, Basic Auto, and Program Auto modes, powered by mains or non-detachable lithium-ion battery, with technical alarms for high pressure, power failure, and sensor faults—features comparable to the CoughAssist T70 predicate.

IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-6:2020 (usability), IEC 60601-1-8:2020 (alarm systems), HA60601-1-11:2015+A1:2021 (home use), ISO 80601-2-61:2017 (pulse oximetry), ISO 10993-1 (biocompatibility), ISO 18562-1/2/3:2017 (breathing gas pathway emissions), and ISO 14971 (safety risk management).

Clearo has identical intended use, same patient populations, and substantially similar core technology (blower-valve insufflation-exsufflation mechanism) as the CoughAssist T70 predicate. The main differences—technical alarms and optional oscillations (1–20 Hz)—are not new to medical devices and do not raise novel safety or effectiveness questions; the oscillation feature is already cleared in the BiWaze reference device. Comparative waveform testing confirms comparable pressure delivery across all modes, supporting functional equivalence.