510(k) · Cleared
ClearedMySleepDash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnetics International, Inc. (Dba Transcend Inc) · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Apr 17, 2026 as substantially equivalent to K160836 (Resmed, Ltd., 2016) after a 263-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Apr 17, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913396 (1992). 51 ancestors in all, the oldest K905404 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations between
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK140124 S9 EloueraResmed Corp · 2014
- 1 generation backK160836 Menai SystemResmed, Ltd. · 2016
- This deviceK252338 MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026
Show all 10 generations
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 8 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 7 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 6 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 5 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 4 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK140124 S9 EloueraResmed Corp · 2014
- 1 generation backK160836 Menai SystemResmed, Ltd. · 2016
- This deviceK252338 MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −9 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −8 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −7 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −6 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −5 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −4 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −3 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −2 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| −1 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| 0 (this device) | K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160836 | Menai SystemSummary page 5…uct Code: BZD Predicate Device: Monte Carlo (mobile applica on in the Menai System) K160836 Submission Reason: New Device Device Descrip on: The MySleepDash Mobile Applica on is a cross-pla orm m… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 51 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160836.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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…
Read the full statement (113 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252338 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252338: MySleepDash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252338
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026