510(k) · Cleared
ClearedAutoset Spirit Cpap 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 Jul 16, 2002 as substantially equivalent to K980721 (Resmed, Ltd., 1998) and 1 other predicate after a 238-day review. Its family tree reaches back 1 generation to 1997. 12 of the 128 devices in its family, counting itself, have a Class I recall. 125 later devices descend from it.
- Decided
- Jul 16, 2002
- Review
- 238 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971260 (1997). 2 ancestors in all. 125 later devices descend from it, 7 citing it directly. 12 of the 128 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- This deviceK013843 Autoset Spirit Cpap SystemResmed Corp · 2002
- Descendant · cites it directly · 110 of its ownK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- Descendant · 2 generations on · 100 of its ownK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 96 of its ownK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 41 of its ownK062291 Vpap Malibu with H2IResmed, Ltd. · 2006
- Descendant · 2 generations on · 40 of its ownK071171 Vpap Auto with H3IResmed, Ltd. · 2007
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 125 · See all- K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003 · cites it directly110descendants
- K033841Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · 2 generations on100descendants
- K041209Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · cites it directly96descendants
- K062291Vpap Malibu with H2IResmed, Ltd. · 2006 · cites it directly41descendants
- K071171Vpap Auto with H3IResmed, Ltd. · 2007 · 2 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| 0 (this device) | K013843 | Autoset Spirit Cpap System | Resmed Corp | 2002 | — |
| +1 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| +2 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| +1 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| +1 | K062291 | Vpap Malibu with H2I | Resmed, Ltd. | 2006 | — |
| +2 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 11 | 1 |
| 2010 | 4 | 1 |
| 2011 | 8 | 3 |
| 2012 | 14 | 3 |
| 2013 | 10 | 2 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K980721 | Sullivan AutosetSummary page 1…trates Substantial Equivalence of the AUTOSET SPIRITCPAP System (including the integrated humidifier) with the predicate ResMed Sullivan AutoSet CPAP System (K980721) and the predicate ResMed Sullivan HumidAire Heated Humidifier (K971260). (The Sullivan AutoSet CPAP System was cleared for… | 1998 |
| * | K971260 | Sullivan Humidaire Heated HumidifierSummary page 1…ng the integrated humidifier) with the predicate ResMed Sullivan AutoSet CPAP System (K980721) and the predicate ResMed Sullivan HumidAire Heated Humidifier (K971260). (The Sullivan AutoSet CPAP System was cleared for use with the Sullivan HumidAire Heated Humidifier.)… | 1997 |
What descends from it? (125)
See all 1257 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | 2003 | 110 |
| K041209 | Resmed S8 Pioneer Cpap System | 2004 | 96 |
| K062291 | Vpap Malibu with H2I | 2006 | 41 |
| K030797 | S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx… | 2004 | 17 |
| K032480 | Autoset Spirit System | 2003 | 6 |
| K080797 | Humidaire 2I | 2008 | 2 |
| K121374 | ZI Blower | 2013 | 1 |
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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 8 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?
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 AUTOSETSPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE 2iTM) is indicated for the humidification and warming of air from the AUTOSETSPIRIT flow generator device. The AUTOSETSPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013843: Autoset Spirit Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013843
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026