510(k) · Cleared
ClearedSullivan Autoset
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 Sep 1, 1998 after a 189-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 of the 246 devices in its family, counting itself, have a Class I recall. 245 later devices descend from it.
- Decided
- Sep 1, 1998
- Review
- 189 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
245 later devices descend from it, 6 citing it directly. 26 of the 246 devices in this family, counting this one, have a Class I recall.
- This deviceK980721 Sullivan AutosetResmed, Ltd. · 1998
- Descendant · cites it directly · 128 of its ownK013909 S7 Elite CP AP SystemResmed Corp · 2002
- Descendant · cites it directly · 125 of its ownK013843 Autoset Spirit Cpap SystemResmed Corp · 2002
- Descendant · 2 generations on · 110 of its ownK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- Descendant · 2 generations on · 106 of its ownK030843 Vpap IiiResmed, Ltd. · 2003
- Descendant · 3 generations on · 100 of its ownK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
Showing 5 of 245 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 245 · See all- K013909S7 Elite CP AP SystemResmed Corp · 2002 · cites it directly128descendants
- K013843Autoset Spirit Cpap SystemResmed Corp · 2002 · cites it directly125descendants
- K024191S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003 · 2 generations on110descendants
- K030843Vpap IiiResmed, Ltd. · 2003 · 2 generations on106descendants
- K033841Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · 3 generations on100descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980721 | Sullivan Autoset | Resmed, Ltd. | 1998 | — |
| +1 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| +1 | K013843 | Autoset Spirit Cpap System | Resmed Corp | 2002 | — |
| +2 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| +2 | K030843 | Vpap Iii | Resmed, Ltd. | 2003 | — |
| +3 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 10 | 1 |
| 2008 | 11 | 1 |
| 2009 | 20 | 1 |
| 2010 | 10 | 1 |
| 2011 | 16 | 3 |
| 2012 | 25 | 5 |
| 2013 | 22 | 4 |
| 2014 | 11 | 0 |
| 2015 | 7 | 1 |
| 2016 | 13 | 2 |
| 2017 | 5 | 1 |
| 2018 | 5 | 1 |
| 2019 | 7 | 4 |
| 2020 | 7 | 0 |
| 2021 | 6 | 1 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
26 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (245)
See all 2456 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (26 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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K183512Moore Park MaskResmed, Ltd. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K120463Mojo, VerasealSleepnet Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K063806Sleepnet Mojo -NV Full Face Mask, Non-VentedSleepnet Corporation · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K081743Classicstar NV SE and Novastar NV SE and Aav Full Face MasksDraeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K190254Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K190533Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented…Sleepnet Corporation · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
Nearest 12 of 26 shown.
Nearest 5 of 26; all are on the web page.
What does this lineage say?
- Of its descendants, K013909 (Resmed Corp, 2002) has gone furthest, with 128 descendants of its own.
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?
Treatment of obstructive sleep apnea in adult patients.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980721: Sullivan Autoset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980721
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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