510(k) · Cleared
ClearedMenai System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 15, 2016 as substantially equivalent to K140124 (Resmed Corp, 2014) and 1 other predicate after a 265-day review. Its family tree reaches back 9 generations to 1992. 6 later devices descend from it.
- Decided
- Dec 15, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K913396 (1992). 50 ancestors in all, the oldest K905404 (1991). 6 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 5 generations between
- 3 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 2 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 1 generation backK140124 S9 EloueraResmed Corp · 2014
- This deviceK160836 Menai SystemResmed, Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK200565 GalapogosResmed Corp · 2021
- Descendant · 2 generations on · 2 of its ownK241216 myAirResmed Corp · 2024
- Descendant · 3 generations on · 1 of its ownK250624 myAirResmed Corp · 2025
- Descendant · cites it directly · 0 of its ownK252338 MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026
- Descendant · 4 generations on · 0 of its ownK251657 Personalized Therapy Comfort Settings (PTCS)Resmed Corp · 2025
Show all 9 generations
- Root · 9 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 8 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 7 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 6 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 5 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 4 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 3 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 2 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 1 generation backK140124 S9 EloueraResmed Corp · 2014
- This deviceK160836 Menai SystemResmed, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200565GalapogosResmed Corp · 2021 · cites it directly3descendants
- K241216myAirResmed Corp · 2024 · 2 generations on2descendants
- K250624myAirResmed Corp · 2025 · 3 generations on1descendant
- K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026 · cites it directly0descendants
- K251657Personalized Therapy Comfort Settings (PTCS)Resmed Corp · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −8 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −7 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −6 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −5 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −4 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −3 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −2 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −1 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| 0 (this device) | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| +1 | K200565 | Galapogos | Resmed Corp | 2021 | — |
| +2 | K241216 | myAir | Resmed Corp | 2024 | — |
| +3 | K250624 | myAir | Resmed Corp | 2025 | — |
| +1 | K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026 | — |
| +4 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K140124 | S9 EloueraSummary page 4…ous ventilator (IPPB) Breathing Frequency Monitor Proprietary Name Menai system Predicate Device(s) S9 Elouera (K140124) Medtronic® SULLIVAN CPAP System (K905404) Reason for submission New Device… | 2014 |
| * | K905404 | Medtronic Sullivan Nasal Cpap SystemSummary page 4…Monitor Proprietary Name Menai system Predicate Device(s) S9 Elouera (K140124) Medtronic® SULLIVAN CPAP System (K905404) Reason for submission New Device… | 1991 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 50 ancestors have a recall of any class.
- Of its descendants, K200565 (Resmed Corp, 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K140124.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use. Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, analyze and display usage and therapeutic information. Monte Carlo also allows…
Read the full statement (146 words)
The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use.
Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, analyze and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices.
The Menai FFM is a non-invasive accessory used for channeling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system. The Menai FFM is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home and hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160836: Menai System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160836
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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