510(k) · Cleared
ClearedAutoset Spirit 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 Oct 16, 2003 as substantially equivalent to K013843 (Resmed Corp, 2002) after a 65-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Oct 16, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971260 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 1 generation backK013843 Autoset Spirit Cpap SystemResmed Corp · 2002
- This deviceK032480 Autoset Spirit SystemResmed, Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK083656 Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009
- Descendant · 2 generations on · 2 of its ownK112079 Apex Medical XT Auto Cpap with Compliance Improvement Algorithm…Apex Medical Corp. · 2012
- Descendant · 2 generations on · 2 of its ownK120035 Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012
- Descendant · 3 generations on · 1 of its ownK141522 Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014
- Descendant · 4 generations on · 0 of its ownK150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083656Apex Medical XT Auto Cpap 9S-005200Apex Medical Corp. · 2009 · cites it directly4descendants
- K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp. · 2012 · 2 generations on2descendants
- K120035Apex Medical Ich Cpap Series (9S-007XXX)Apex Medical Corp. · 2012 · 2 generations on2descendants
- K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014 · 3 generations on1descendant
- K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015 · 4 generations on0descendants
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 | K013843 | Autoset Spirit Cpap System | Resmed Corp | 2002 | — |
| 0 (this device) | K032480 | Autoset Spirit System | Resmed, Ltd. | 2003 | — |
| +1 | K083656 | Apex Medical XT Auto Cpap 9S-005200 | Apex Medical Corp. | 2009 | — |
| +2 | K112079 | Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 | Apex Medical Corp. | 2012 | — |
| +2 | K120035 | Apex Medical Ich Cpap Series (9S-007XXX) | Apex Medical Corp. | 2012 | — |
| +3 | K141522 | Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series | Apex Medical Corp. | 2014 | — |
| +4 | K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Apex Medical Corp. | 2015 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K013843 | Autoset Spirit Cpap System | 2002 |
What descends from it? (6)
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 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083656 (Apex Medical Corp., 2009) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K013843.
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 AUTOSET SPIRIT self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The AUTOSET SPIRIT self-adjusting sleep apnea system has two treatment modes (auto-titrating and fixed-pressure CPAP).
The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT self-adjusting sleep apnea System and HUMIDAIRE 2i are for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032480: Autoset Spirit System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032480
Report an extraction error
Are you the manufacturer?
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