# K252338: MySleepDash

- Pathway: 510(k) (Traditional)
- Applicant: Somnetics International, Inc. (Dba Transcend Inc)
- Decided: Apr 17, 2026 after 263 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913396 (1992). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160836: Menai System, Resmed, Ltd. (2016) Summary page 5.

## Indications for use
The MySleepDash Mobile Application software is intended to be used in conjunction with Transcend Continuous Positive Airway Pressure (CPAP) devices to support individuals diagnosed with obstructive sleep apnea (OSA). The application enables users to view therapy data, monitor device usage, and adjust comfort settings. The application is also intended for healthcare professionals to configure Transcend CPAP device settings. It does not provide automated diagnosis or treatment recommendations and should be used in conjunction with professional medical oversight. Transcend CPAP devices are intended for use in adults adults weighing over 66 pounds (30 kg). These devices are intended for home and hospital/institutional use. This mobile health application is for prescription use only (Rx Only).

Source page: https://510kreport.com/device/K252338
Methodology: https://510kreport.com/methodology