510(k) · Cleared
ClearedRespironics Sleepeasy Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 15, 2009 as substantially equivalent to K010263 (Respironics, Inc., 2001) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1996. 2 of the 13 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- May 15, 2009
- Review
- 28 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953930 (1996). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 3 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 2 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 1 generation backK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
- This deviceK091112 Respironics Sleepeasy Cpap SystemRespironics, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK122769 Remstar SERespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK130077 Remstar SERespironics, Inc. · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK200480 DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020
- Descendant · 4 generations on · 0 of its ownK251770 SleepRes PAP SystemSleepres, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K122769Remstar SERespironics, Inc. · 2012 · cites it directly3descendants
- K130077Remstar SERespironics, Inc. · 2013 · 2 generations on2descendants
- K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020 · 3 generations on1descendant
- K251770SleepRes PAP SystemSleepres, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −2 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −1 | K021861 | Remstar Pro with C-Flex Cpap System | Respironics, Inc. | 2002 | 1 |
| 0 (this device) | K091112 | Respironics Sleepeasy Cpap System | Respironics, Inc. | 2009 | — |
| +1 | K122769 | Remstar SE | Respironics, Inc. | 2012 | Class I |
| +2 | K130077 | Remstar SE | Respironics, Inc. | 2013 | Class I |
| +3 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020 | — |
| +4 | K251770 | SleepRes PAP System | Sleepres, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2013 | 1 | 1 |
| 2020 | 1 | 0 |
| 2025 | 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.
2 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? (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 |
|---|---|---|---|
| * | K010263 | Remstar Plus Cpap SystemSummary page 1…Yurko @ Respironics.com 21 CFR 868.5905 BZD - Non-Continuous yent.i‘qutbr : CPAP ‘System ‘ Respironics ‘SleepEaéy- CPAP ‘System Respironics REMstar Plis CPAP System (K010263) ‘Respironics REMstar Pro with C-Flex CPAP System (K021861) Modified design. ©2009 Respironics Inc. 4/16/2009 000639 === Pa… | 2001 |
| * | K021861 | Remstar Pro with C-Flex Cpap SystemSummary page 1…us yent.i‘qutbr : CPAP ‘System ‘ Respironics ‘SleepEaéy- CPAP ‘System Respironics REMstar Plis CPAP System (K010263) ‘Respironics REMstar Pro with C-Flex CPAP System (K021861) Modified design. ©2009 Respironics Inc. 4/16/2009 000639 Respironics SleepEasy CPAP System… | 2002 |
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 |
|---|---|---|---|
| K122769 | Remstar SE Class I | 2012 | 3 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K122769 (Respironics, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K010263.
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 Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091112: Respironics Sleepeasy Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091112
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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