510(k) · Cleared
ClearedRemstar M-Series Auto with Aflex Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 8, 2009 as substantially equivalent to K063830 (Respironics Inc., Sleep & Home Respiratory Group, 2007) after a 95-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- May 8, 2009
- Review
- 95 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K953930 (1996). 29 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 7 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 6 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 5 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 4 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 3 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 2 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 1 generation backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- This deviceK090243 Remstar M-Series Auto with Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −7 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −6 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −5 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −4 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −3 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −2 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −1 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| 0 (this device) | K090243 | Remstar M-Series Auto with Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K063830 | Remstar Aflex Cpap SystemSummary page 1…roprietary Name Respironics REMstar M-Series Auto with AFLEX CPAP System Predicate Device(s) Respironics REIVstar AFLEX CPAP System (K063830) Reason for submission modified device Substantial Equivalence The modified device has the following simila… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 29 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063830.
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 REMstar M-Series Auto with AFLEX CPAP System delivers positive
airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously
breathing patients weighing over 30kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090243: Remstar M-Series Auto with Aflex 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/K090243
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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