510(k) · Cleared
ClearedS8 Advance
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 Jan 2, 2009 as substantially equivalent to K080079 (Resmed, Ltd., 2008) and 1 other predicate after an 88-day review. Its family tree reaches back 6 generations to 1997. 3 later devices descend from it.
- Decided
- Jan 2, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971260 (1997). 12 ancestors in all, the oldest K930656 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 5 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 4 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 3 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 2 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 1 generation backK080079 S8 Escape IIResmed, Ltd. · 2008
- This deviceK082979 S8 AdvanceResmed, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK112079 Apex Medical XT Auto Cpap with Compliance Improvement Algorithm…Apex Medical Corp. · 2012
- Descendant · 2 generations on · 1 of its ownK141522 Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014
- Descendant · 3 generations on · 0 of its ownK150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015
Most influential descendants
Showing 3 of 3 · See all- K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex Medical Corp. · 2012 · cites it directly2descendants
- K141522Apex Medical Corp. Ich Cpap with Pva 9S-007XXX SeriesApex Medical Corp. · 2014 · 2 generations on1descendant
- K150111Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesApex Medical Corp. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −5 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −4 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −3 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −2 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −1 | K080079 | S8 Escape II | Resmed, Ltd. | 2008 | — |
| 0 (this device) | K082979 | S8 Advance | Resmed, Ltd. | 2009 | — |
| +1 | K112079 | Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 | Apex Medical Corp. | 2012 | — |
| +2 | K141522 | Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series | Apex Medical Corp. | 2014 | — |
| +3 | 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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 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? (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 |
|---|---|---|---|
| * | K080079 | S8 Escape IISummary page 1…Code 73,BZD Common/Usual Name Non continuous ventilator.(IPPB):. Proprietary Name S8 ADVANCE Predicate Device(s) S8 Escape 11(K080079) 58 Pioneer (KO41209) Reason for submission New Device Indication for Use The S8 ADVANCE self-… | 2008 |
| * | K041209 | Resmed S8 Pioneer Cpap SystemSummary page 2…-Shelf Software Use in Medical Devices (September 9,1999) Conclusion The S8 ADVANCE System is substantially equivalent to the S8 Escape II(K080079) and the S8 Pioneer (K041209). 3 rd October, 2008 Page 18 DEPA… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112079 | Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 | 2012 | 2 |
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 12 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K112079 (Apex Medical Corp., 2012) has gone furthest, with 2 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. 2009, this device’s year, is highlighted.
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 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA)
in adult patients.
The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP.
The S8 ADVANCE system is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082979 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082979: S8 Advance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082979
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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