510(k) · Cleared
ClearedS8 Escape II
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 Apr 8, 2008 as substantially equivalent to K033841 (Resmed, Ltd., 2004) and 2 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 8, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K971260 (1997). 11 ancestors in all, the oldest K930656 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 4 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 3 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 2 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 1 generation backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- This deviceK080079 S8 Escape IIResmed, Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK082979 S8 AdvanceResmed, Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK112079 Apex Medical XT Auto Cpap with Compliance Improvement Algorithm…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
Most influential descendants
Showing 4 of 4 · See all- K082979S8 AdvanceResmed, Ltd. · 2009 · cites it directly3descendants
- K112079Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720Apex 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 |
|---|---|---|---|---|---|
| −5 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −4 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −3 | 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 |
| 0 (this device) | K080079 | S8 Escape II | Resmed, Ltd. | 2008 | — |
| +1 | K082979 | S8 Advance | Resmed, Ltd. | 2009 | — |
| +2 | K112079 | Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K033841 | Resmed S8 Prime Cpap SystemSummary page 1…73 BZD Common/Usual Name Non continuous ventilator (IPPB). Proprietary Name S8 ESCAPE II CPAP System Predicate Device(s) S8 Prime (K033841) S8 Pioneer (K041209 S7 Elite (K010909) Reason for submission New… | 2004 |
| * | K041209 | Resmed S8 Pioneer Cpap SystemSummary page 1…ntinuous ventilator (IPPB). Proprietary Name S8 ESCAPE II CPAP System Predicate Device(s) S8 Prime (K033841) S8 Pioneer (K041209 S7 Elite (K010909) Reason for submission New Device Indication for Use The S8 ESCAPE II CPAP… | 2004 |
| * | K010909 | Nonabsorbable Polypropylene Surgical SutureSummary page 1…S8 ESCAPE II CPAP System Predicate Device(s) S8 Prime (K033841) S8 Pioneer (K041209 S7 Elite (K010909) Reason for submission New Device Indication for Use The S8 ESCAPE II CPAP system is indicated for the treatment of obst… | 2001 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082979 | S8 Advance | 2009 | 3 |
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 11 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K082979 (Resmed, Ltd., 2009) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K033841.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 ESCAPE II CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 ESCAPE II is intended for hospital and home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080079 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080079: S8 Escape II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080079
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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