Compal Electronics, Inc. · Class II · Cleared Mar 17, 2026
| K-number | K252078 |
| Device name | BreathePal Bilevel (GFM50-MD2201) |
| Applicant | Compal Electronics, Inc. |
| Product code | MNS |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 868.5895 |
The BreathePal Bilevel is a non-invasive ventilation device that delivers two distinct pressure levels—a higher pressure during inhalation (IPAP) and lower pressure during exhalation (EPAP)—to support adult patients weighing over 30 kg with Obstructive Sleep Apnea and Respiratory Impairment. It is microprocessor-controlled, battery-capable, and intended for use in home and clinical environments including hospitals and sleep laboratories.
The BreathePal Bilevel shares the same blower-based positive airway pressure architecture as the predicate BiPAP A30, with equivalent pressure ranges (IPAP 4–30 cmH2O, EPAP 4–25 cmH2O, CPAP 4–20 cmH2O) and pressure accuracy (±2.5 cmH2O). Key differences include: disabling humidifier on battery power (vs. enabled on predicate), mechanical buttons instead of membrane keys, exclusion of the AVAPS-AE mode, and a 1-year humidifier chamber service life. The device does not support volume-targeted ventilation but maintains equivalent monitoring accuracy for displayed tidal volumes.
IEC 60601-1:2020 (Basic Safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-6:2020 and IEC 60601-1-8:2020, IEC 60601-1-11:2020 (Home Healthcare), ISO 80601-2-79:2018 (Ventilatory Support), ISO 80601-2-74:2021 (Humidifier), ISO 10993-1:2018 (Biocompatibility), ISO 18562-1:2017 (Breathing Gas Pathways), IEC 62304:2015 (Software Life Cycle), and FDA guidance on Human Factors Engineering (2016).
The BreathePal Bilevel is substantially equivalent to the BiPAP A30 because both devices share identical classification, product code (MNS), intended use (non-invasive ventilation for adult OSA and respiratory impairment patients), and clinical environments. Comprehensive bench testing demonstrates equivalent essential performance per ISO 80601-2-79; pressure delivery, alarm functionality, and monitoring accuracy are comparable. Minor technological differences (mechanical buttons, battery-dependent humidifier logic, absence of AVAPS-AE) do not raise new safety or effectiveness questions, as they either improve robustness or simplify the device without compromising standard therapy modes.
View the full FDA submission: accessdata.fda.gov