510(k) · Cleared
Recalled · Class I · 2021Remstar SE
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 21, 2013 as substantially equivalent to K122769 (Respironics, Inc., 2012) after a 127-day review. Its family tree reaches back 11 generations to 1996. 4 of the 36 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- May 21, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 11 generations to K953930 (1996). 33 ancestors in all, the oldest K930656 (1994). 2 later devices descend from it, 1 citing it directly. 4 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 7 generations between
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- 1 generation backK122769 Remstar SERespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK130077 Remstar SERespironics, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK200480 DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251770 SleepRes PAP SystemSleepres, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 10 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 9 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 8 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 7 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 6 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 5 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 4 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- 1 generation backK122769 Remstar SERespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK130077 Remstar SERespironics, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −10 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −9 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −8 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −7 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −6 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −5 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −3 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −2 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | Class I |
| −1 | K122769 | Remstar SE | Respironics, Inc. | 2012 | Class I |
| 0 (this device) | K130077 | Remstar SE | Respironics, Inc. | 2013 | — |
| +1 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020 | — |
| +2 | K251770 | SleepRes PAP System | Sleepres, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
4 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? (1)
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 |
|---|---|---|---|
| * | K122769 | Remstar SESummary page 1…ventilator, non-continuous (respirator) (21 CFR 858.5905, Product Code BZD) Predicate Device Respironics REMstar SE (K122769) Reason for Submission The modified device is the result of a material modifications mad… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | 2020 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2021 | Class I | Z-1974-2021 | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
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.
- K122769Remstar SERespironics, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 12 of the 33 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K200480 (Respironics, Inc., 2020) has gone furthest, with 1 descendant 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. 2013, 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 REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 Ibs). It is for use in the home or hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130077: Remstar SE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130077
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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