BMC Medical Co., Ltd. · Class II · Cleared Jan 15, 2025
| K-number | K242935 |
| Device name | Respiration Data Management Software (PAP Link PC) |
| Applicant | BMC Medical Co., Ltd. |
| Product code | BZD |
| Device class | Class II |
| Decision date | Jan 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5905 |
The Respiration Data Management Software is a PC-based application that allows healthcare professionals to view, report on, and remotely adjust settings for compatible BMC CPAP and BPAP devices. It is used in professional healthcare facilities only for patient management and follow-up care, enabling data transmission, analysis, and review of respiratory therapy information.
The subject device operates on Microsoft Windows, communicates via serial connection, removable media, and wireless TCP/HTTPS (unlike the predicate which lacked wireless capability), displays therapy data including mask leak, AHI, pressure, minute ventilation, and respiratory rate, allows remote parameter adjustment on non-life support devices, and includes a cloud data upload function. Both devices are PC-based software programs with similar reporting and settings management capabilities.
Not stated in this summary. The document references Software Verification and Validation per FDA guidance 'Content of Premarket Submissions for Device Software Functions' and Cybersecurity evaluation per FDA guidance 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,' but does not cite specific consensus standards like ISO or IEC.
The subject device shares the same intended use as the predicate (ResScan K140054): software for clinician-based patient management of non-life support respiratory devices in professional settings. Both are Class II PC-based software programs classified under 21 CFR 868.5905. The subject device's additional features—wireless TCP/HTTPS communication and cloud data upload—do not raise new safety or effectiveness concerns because they are supported by documented software verification/validation and cybersecurity testing. The differences in compatible device product codes (subject: BZD, MNS; predicate: BZD, MNS, MNT, CBK) and changeable settings are minor and do not introduce new risks since both share compatibility with the core BZD and MNS device families.
View the full FDA submission: accessdata.fda.gov