510(k) · Cleared
Recalled · 2007Resmed S8 Pioneer Cpap 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 Jul 1, 2004 as substantially equivalent to K013843 (Resmed Corp, 2002) and 2 other predicates after a 52-day review. Its family tree reaches back 4 generations to 1997. 12 of the 106 devices in its family, counting itself, have a Class I recall. 96 later devices descend from it. It has been recalled once.
- Decided
- Jul 1, 2004
- Review
- 52 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K971260 (1997). 9 ancestors in all, the oldest K930656 (1994). 96 later devices descend from it, 6 citing it directly. 12 of the 106 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 3 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 2 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 1 generation backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- This deviceK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004
- Descendant · cites it directly · 40 of its ownK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- Descendant · cites it directly · 38 of its ownK080131 Vpap STResmed, Ltd. · 2008
- Descendant · cites it directly · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · 2 generations on · 33 of its ownK082605 Vpap Auto with Humidaire 3IResmed, Ltd. · 2009
- Descendant · 2 generations on · 31 of its ownK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 96 · See all- K071171Vpap Auto with H3IResmed, Ltd. · 2007 · cites it directly40descendants
- K080131Vpap STResmed, Ltd. · 2008 · cites it directly38descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly35descendants
- K082605Vpap Auto with Humidaire 3IResmed, Ltd. · 2009 · 2 generations on33descendants
- K091947S8 Aspen with H4I PlusResmed, Ltd. · 2009 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −3 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −2 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −1 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| 0 (this device) | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | — |
| +1 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| +1 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| +1 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +2 | K082605 | Vpap Auto with Humidaire 3I | Resmed, Ltd. | 2009 | — |
| +2 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 9 | 1 |
| 2010 | 4 | 1 |
| 2011 | 7 | 3 |
| 2012 | 11 | 3 |
| 2013 | 6 | 2 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 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 | 8 | 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? (3)
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 SystemSummary page 1…s Ventilator Common/Usual Name CPAP System Proprietary Name S8~ Pioneer CPAP System Predicate Device(s) AutoSet Spirit (K01 3843) S8 Prime (K033841) VPAP Ill (K030843) Reason for submission… | 2002 |
| * | K033841 | Resmed S8 Prime Cpap SystemSummary page 1…System Proprietary Name S8~ Pioneer CPAP System Predicate Device(s) AutoSet Spirit (K01 3843) S8 Prime (K033841) VPAP Ill (K030843) Reason for submission New Device Indications for Use… | 2004 |
| * | K030843 | Vpap IiiSummary page 1…r CPAP System Predicate Device(s) AutoSet Spirit (K01 3843) S8 Prime (K033841) VPAP Ill (K030843) Reason for submission New Device Indications for Use The 58 Pioneer self-adjusting sleep apnea syste… | 2003 |
What descends from it? (96)
See all 966 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2007 | Not classified | Z-1006-2007 | Other | S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure… |
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.
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 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
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 7 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 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K071171 (Resmed, Ltd., 2007) has gone furthest, with 40 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 S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).
The S8 Pioneer system is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041209: Resmed S8 Pioneer Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041209
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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