510(k) · Cleared
ClearedS7 Elite and Autoset Spirit Cpap Systems with Reslink
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 Jul 2, 2003 as substantially equivalent to K013909 (Resmed Corp, 2002) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 1997. 12 of the 115 devices in its family, counting itself, have a Class I recall. 110 later devices descend from it.
- Decided
- Jul 2, 2003
- Review
- 194 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971260 (1997). 4 ancestors in all. 110 later devices descend from it, 5 citing it directly. 12 of the 115 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 1 generation backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- This deviceK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- Descendant · cites it directly · 100 of its ownK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- Descendant · 2 generations on · 96 of its ownK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- Descendant · 3 generations on · 40 of its ownK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- Descendant · 3 generations on · 38 of its ownK080131 Vpap STResmed, Ltd. · 2008
- Descendant · 3 generations on · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 110 · See all- K033841Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · cites it directly100descendants
- K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · 2 generations on96descendants
- K071171Vpap Auto with H3IResmed, Ltd. · 2007 · 3 generations on40descendants
- K080131Vpap STResmed, Ltd. · 2008 · 3 generations on38descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on35descendants
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) | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| +1 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| +2 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| +3 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| +3 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| +3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 9 | 1 |
| 2010 | 4 | 1 |
| 2011 | 8 | 3 |
| 2012 | 13 | 3 |
| 2013 | 8 | 2 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 1 |
| 2020 | 6 | 0 |
| 2021 | 3 | 1 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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.
12 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K013909 | S7 Elite CP AP SystemSummary page 1…S7TMElite and Autoset@SpiritTMCPAP Systems with ResLinkTM Predicate Device(s) ResMed, S71MElite CPAP System (K013909) ResMed, Autoset' SpiritTMCPAP System (KO1384311 Reason for submission Modified de… | 2002 |
| * | K013843 | Autoset Spirit Cpap System | 2002 |
What descends from it? (110)
See all 1105 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (12 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K033841 (Resmed, Ltd., 2004) has gone furthest, with 100 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 S7 Elite and AUTOSET@SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the S7 Elite or AUTOSET@SPIRIT flow generator device. The S7 Elite and AUTOSET@SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024191 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024191
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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