510(k) · Cleared
ClearedModification to Remstar Auto 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 Jun 24, 2003 as substantially equivalent to K012554 (Respironics, Inc., 2002) and 1 other predicate after a 47-day review. Its family tree reaches back 3 generations to 1996. 12 of the 80 devices in its family, counting itself, have a Class I recall. 74 later devices descend from it.
- Decided
- Jun 24, 2003
- Review
- 47 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953930 (1996). 5 ancestors in all. 74 later devices descend from it, 3 citing it directly. 12 of the 80 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 2 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 1 generation backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- This deviceK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- Descendant · cites it directly · 40 of its ownK041010 Remstar Auto with C-Flex Cpap SystemRespironics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 40 of its ownK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- Descendant · 2 generations on · 39 of its ownK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- Descendant · 2 generations on · 37 of its ownK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 35 of its ownK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 74 · See all- K041010Remstar Auto with C-Flex Cpap SystemRespironics, Inc. · 2004 · cites it directly40descendants
- K032834Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004 · cites it directly40descendants
- K043607Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005 · 2 generations on39descendants
- K050759Bipap AutoRespironics, Inc. · 2005 · 2 generations on37descendants
- K063830Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −2 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −1 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| 0 (this device) | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| +1 | K041010 | Remstar Auto with C-Flex Cpap System | Respironics, Inc. | 2004 | 3 |
| +1 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| +2 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| +2 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| +3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 1 |
| 2010 | 2 | 1 |
| 2011 | 3 | 3 |
| 2012 | 5 | 3 |
| 2013 | 6 | 2 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 1 |
| 2020 | 7 | 0 |
| 2021 | 3 | 1 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K012554 | Remstar Auto Cpap System | 2002 |
| * | K993433 | Virtuoso LX Smart Cpap SystemSummary page 1…System Predicate Device(s) Respironics REMstar Auto CPAP System (KO12554) Respironics Virtuoso LX Smart CPAP System (K993433) Reason for submission Modified design, additional accessories. Substantial Equivalence The modified device… | 1999 |
What descends from it? (74)
See all 743 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)
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.
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 6 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 6 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 7 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 8 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 9 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 1 company; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K041010 (Respironics, Inc., 2004) has gone furthest, with 40 descendants of its own.
- 6 other devices also cite its predicate K012554.
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 REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.
For use in the home or hospital/institutional environment on adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031460: Modification to Remstar Auto 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/K031460
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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