Makani Science™ Respiration Monitoring System

The Makani Science Respiration Monitoring System is a wireless respiratory rate monitoring device consisting of two adhesive-mounted piezo-resistive strain sensors applied to the chest and abdomen, paired via Bluetooth to an iPad app. It continuously displays breathing rate graphically and numerically in real-time and is intended for use by healthcare professionals in hospitals and dental offices on adult patients aged 22 and older to monitor respiration, but not for apnea detection.

The device uses piezo-resistive strain sensors (versus the predicate's piezo-electric sensor) but both measure torso movement to calculate respiratory rate. Both employ dual chest-mounted adhesive sensors with Bluetooth wireless connection; the Makani uses BLE 5.0 versus the predicate's BLE 4.2. Both achieve ±3 BPM accuracy over a 4–60 BPM range, though the Makani has a 12-month shelf life compared to the predicate's 24 months.

Biocompatibility: ISO 10993-1:2018. Shelf-life: ASTM F1980-21. Electrical safety: IEC 60601-1:2005 with amendments. EMC: IEC 60601-1-2:2014 and ANSI C63.27-2017. Software: IEC 62304:2006. Usability and alarms: IEC 60601-1-6:2013 and IEC 60601-1-8:2020. Performance bench testing also cited FDA guidance on software, cybersecurity, and wireless technology.

The Makani RMS is substantially equivalent because it employs the same technological principle as the predicate (torso-mounted sensors measuring respiratory rate via chest wall movement), achieves identical accuracy (±3 BPM), and maintains comparable performance characteristics including shelf-life, connectivity method, and measurement range. Clinical testing on 29 subjects validated RR accuracy against capnography across multiple postures, demographics, and conditions. The minor differences—piezo-resistive versus piezo-electric sensor type, slightly higher Bluetooth version, restricted patient age (≥22 vs. ≥18 years), and no-motion-only use—do not raise new safety or effectiveness questions because the narrower intended use and patient population are subsets of the predicate's scope.