510(k) · Cleared
ClearedmyAir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 26, 2024 as substantially equivalent to K200565 (Resmed Corp, 2021) after a 148-day review. Its family tree reaches back 11 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 26, 2024
- Review
- 148 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913396 (1992). 52 ancestors in all, the oldest K905404 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations between
- 3 generations backK140124 S9 EloueraResmed Corp · 2014
- 2 generations backK160836 Menai SystemResmed, Ltd. · 2016
- 1 generation backK200565 GalapogosResmed Corp · 2021
- This deviceK241216 myAirResmed Corp · 2024
- Descendant · cites it directly · 1 of its ownK250624 myAirResmed Corp · 2025
- Descendant · 2 generations on · 0 of its ownK251657 Personalized Therapy Comfort Settings (PTCS)Resmed Corp · 2025
Show all 11 generations
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 10 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 9 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 8 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 7 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 6 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 5 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 4 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 3 generations backK140124 S9 EloueraResmed Corp · 2014
- 2 generations backK160836 Menai SystemResmed, Ltd. · 2016
- 1 generation backK200565 GalapogosResmed Corp · 2021
- This deviceK241216 myAirResmed Corp · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −10 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −9 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −8 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −7 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −6 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −5 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −4 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −3 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| −2 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| −1 | K200565 | Galapogos | Resmed Corp | 2021 | — |
| 0 (this device) | K241216 | myAir | Resmed Corp | 2024 | — |
| +1 | K250624 | myAir | Resmed Corp | 2025 | — |
| +2 | K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250624 | myAir | 2025 | 1 |
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 32 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 52 ancestors have a recall of any class.
- Of its descendants, K250624 (Resmed Corp, 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 myAir app is indicated for patients:
• prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.
• prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
• new and existing patients of ResMed Air10 and Air11 PAP therapy devices and
• new users who are prescribed a compatible NightOwl home sleep test (HST).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241216: myAir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241216
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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