510(k) · Cleared
ClearedS9 Elouera
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 May 12, 2014 as substantially equivalent to K091947 (Resmed, Ltd., 2009) and 1 other predicate after a 116-day review. Its family tree reaches back 8 generations to 1992. 8 later devices descend from it.
- Decided
- May 12, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913396 (1992). 48 ancestors in all, the oldest K914085 (1991). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 6 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 5 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 4 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 3 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 2 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 1 generation backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- This deviceK140124 S9 EloueraResmed Corp · 2014
- Descendant · cites it directly · 6 of its ownK160836 Menai SystemResmed, Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK200565 GalapogosResmed Corp · 2021
- Descendant · 3 generations on · 2 of its ownK241216 myAirResmed Corp · 2024
- Descendant · 4 generations on · 1 of its ownK250624 myAirResmed Corp · 2025
- Descendant · 2 generations on · 0 of its ownK252338 MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K160836Menai SystemResmed, Ltd. · 2016 · cites it directly6descendants
- K200565GalapogosResmed Corp · 2021 · 2 generations on3descendants
- K241216myAirResmed Corp · 2024 · 3 generations on2descendants
- K250624myAirResmed Corp · 2025 · 4 generations on1descendant
- K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc) · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −7 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −6 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −5 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −4 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −3 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −2 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −1 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| 0 (this device) | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| +1 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| +2 | K200565 | Galapogos | Resmed Corp | 2021 | — |
| +3 | K241216 | myAir | Resmed Corp | 2024 | — |
| +4 | K250624 | myAir | Resmed Corp | 2025 | — |
| +2 | K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K091947 | S8 Aspen with H4I PlusSummary page 1…us ventilator (IPPB) Breathing Frequency Monitor Proprietaty Name S9 Elouera Predicate Device(s) S8 Aspen (K091947) ApneaLink Plus (K083575) Reason for submission New Device ResMed… | 2009 |
| * | K083575 | Apnealink Plus, Model: 22328Summary page 1…thing Frequency Monitor Proprietaty Name S9 Elouera Predicate Device(s) S8 Aspen (K091947) ApneaLink Plus (K083575) Reason for submission New Device ResMed S9 Elouera Tradit… | 2009 |
What descends from it? (8)
2 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 22 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 48 ancestors have a recall of any class.
- Of its descendants, K160836 (Resmed, Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K091947.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 S9 Elouera self-adjusting device 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140124: S9 Elouera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140124
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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