Somnetics International, Inc. (Dba Transcend Inc) · Class II · Cleared Apr 17, 2026
| K-number | K252338 |
| Device name | MySleepDash |
| Applicant | Somnetics International, Inc. (Dba Transcend Inc) |
| Product code | BZD |
| Device class | Class II |
| Decision date | Apr 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 868.5905 |
MySleepDash is a mobile health application designed to support users of Transcend CPAP devices in managing obstructive sleep apnea (OSA) therapy. The app enables patients to wirelessly view therapy data, monitor device usage, and adjust comfort settings via Bluetooth, while allowing healthcare professionals to configure device settings remotely. It integrates with a secure cloud platform for data storage and remote access, and operates on Android and iOS devices for home and hospital use.
MySleepDash uses Bluetooth Low Energy (BLE) serial port communication with CPAP devices, cloud-based data storage via encrypted HTTPS, and role-based access controls with SHA-256 encryption. It supports multiple languages (English, French, Spanish, Japanese, Korean), includes firmware update capability, and restricts user access to comfort settings only while protecting therapy-critical parameters. The predicate Monte Carlo similarly uses Bluetooth wireless communication and cloud-based storage but with less extensive documentation of cybersecurity controls.
The submission conformed to FDA guidance: 'Content of Premarket Submissions for Device Software Functions' (June 2023) and 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions' (September 2023). Testing included software verification and validation, nonclinical testing, usability engineering studies, and risk management per ISO 13485 requirements.
MySleepDash is substantially equivalent to the Monte Carlo predicate (K160836) because both are mobile software accessories to CPAP devices that provide therapy data display, compliance tracking, and wireless communication with compatible devices. Both limit user interaction to comfort-related settings while restricting access to therapy-critical parameters, use cloud-based data storage architectures, and support safe remote monitoring by clinicians. Differences in documentation transparency and extended language support do not raise new questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov