510(k) · Cleared
ClearedS7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx System
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 Mar 10, 2004 as substantially equivalent to K013909 (Resmed Corp, 2002) and 3 other predicates after a 363-day review. Its family tree reaches back 2 generations to 1997. 17 later devices descend from it.
- Decided
- Mar 10, 2004
- Review
- 363 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K971260 (1997). 6 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 1 generation backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- This deviceK030797 S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap…Resmed Corp · 2004
- Descendant · cites it directly · 16 of its ownK051314 Res Traxx Data CenterResmed, Ltd. · 2005
- Descendant · 2 generations on · 15 of its ownK053205 Res Traxx Data CenterResmed, Ltd. · 2006
- Descendant · 3 generations on · 14 of its ownK070746 Restraxx Data Centre, Model R10Resmed, Ltd. · 2007
- Descendant · 4 generations on · 13 of its ownK083816 Res Traxx Online, Model: R14Resmed, Ltd. · 2009
- Descendant · 5 generations on · 12 of its ownK093684 Easycare OnlineResmed, Ltd. · 2010
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K051314Res Traxx Data CenterResmed, Ltd. · 2005 · cites it directly16descendants
- K053205Res Traxx Data CenterResmed, Ltd. · 2006 · 2 generations on15descendants
- K070746Restraxx Data Centre, Model R10Resmed, Ltd. · 2007 · 3 generations on14descendants
- K083816Res Traxx Online, Model: R14Resmed, Ltd. · 2009 · 4 generations on13descendants
- K093684Easycare OnlineResmed, Ltd. · 2010 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −1 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| 0 (this device) | K030797 | S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with… | Resmed Corp | 2004 | — |
| +1 | K051314 | Res Traxx Data Center | Resmed, Ltd. | 2005 | — |
| +2 | K053205 | Res Traxx Data Center | Resmed, Ltd. | 2006 | — |
| +3 | K070746 | Restraxx Data Centre, Model R10 | Resmed, Ltd. | 2007 | — |
| +4 | K083816 | Res Traxx Online, Model: R14 | Resmed, Ltd. | 2009 | — |
| +5 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K013909 | S7 Elite CP AP SystemSummary page 1…d AutoSet® SpiritTM CPAP Systems with SomnoTraxxTm System TM Predicate Device(s) ResMed, S7TM Elite CPAP System (K01 3909) ResMed, AutoSet® Spirit Tm CPAP System (K01 3843) Ho… | 2002 |
| * | K013843 | Autoset Spirit Cpap SystemSummary page 1…System TM Predicate Device(s) ResMed, S7TM Elite CPAP System (K01 3909) ResMed, AutoSet® Spirit Tm CPAP System (K01 3843) HomMed Sentry III Patient Monitoring System with Card Reader… | 2002 |
| * | K014025 | Hommed Sentry Iii Patient Monitor System with Card ReaderSummary page 1…Spirit Tm CPAP System (K01 3843) HomMed Sentry III Patient Monitoring System with Card Reader K014025 HomMed Central Station K020184 Reason for Submission Modified design - add… | 2002 |
| * | K020184 | Hommed Central StationSummary page 1…HomMed Sentry III Patient Monitoring System with Card Reader K014025 HomMed Central Station K020184 Reason for Submission Modified design - additional accessory Indications for Use… | 2002 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051314 | Res Traxx Data Center | 2005 | 16 |
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 7 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K051314 (Resmed, Ltd., 2005) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K013909.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators. SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute…
Read the full statement (116 words)
The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.
SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.
All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030797 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030797: S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030797
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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