510(k) · Cleared
ClearedRemstar 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 Mar 9, 2007 as substantially equivalent to K052110 (Respironics, Inc., 2005) and 2 other predicates after a 73-day review. Its family tree reaches back 7 generations to 1996. 12 of the 64 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it.
- Decided
- Mar 9, 2007
- Review
- 73 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K953930 (1996). 28 ancestors in all, the oldest K930656 (1994). 35 later devices descend from it, 3 citing it directly. 12 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 5 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 4 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 3 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 2 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 1 generation backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- This deviceK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- Descendant · cites it directly · 22 of its ownK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · cites it directly22descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · cites it directly10descendants
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 2 generations on9descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −6 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −5 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −4 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −3 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −2 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −1 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| 0 (this device) | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| +1 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +2 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| +1 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +2 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | Class I |
| +3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 1 |
| 2010 | 2 | 1 |
| 2011 | 3 | 3 |
| 2012 | 5 | 3 |
| 2013 | 3 | 2 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 3 | 0 |
| 2021 | 2 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040101 | FDA’s K040101 is Modification to Diadexus Plac Test Our OCR of the scanned summary read K040101, FDA’s number for Modification to Diadexus Plac Test (Diadexus, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Respironics REMstar Auto C-Flex CPAP System”. Kept off the family tree. Summary page 1…om 21 CFR 868.5905 BZD — Non-Continuous ventilator CPAP System Respironics REMstar Auto M-Series with AFLEX CPAP System Respironics REMstar Auto C-Flex CPAP System (K040101) Respironics REMstar M Series CPAP System (K052110) Respironics BiPAP Auto Bi-level System (K050759) Resmed S8 Pioneer (K041209… | 2004 |
| * | K052110 | M-Series Pro Cpap SytemSummary page 1…r CPAP System Respironics REMstar Auto M-Series with AFLEX CPAP System Respironics REMstar Auto C-Flex CPAP System (K040101) Respironics REMstar M Series CPAP System (K052110) Respironics BiPAP Auto Bi-level System (K050759) Resmed S8 Pioneer (K041209) Modified design. 3/8/2007 Premarket Notificati… | 2005 |
| * | K050759 | Bipap AutoSummary page 1…with AFLEX CPAP System Respironics REMstar Auto C-Flex CPAP System (K040101) Respironics REMstar M Series CPAP System (K052110) Respironics BiPAP Auto Bi-level System (K050759) Resmed S8 Pioneer (K041209) Modified design. 3/8/2007 Premarket Notification — Special 510(k) (4066 £30 510(K) SUMMARY OF… | 2005 |
| * | K041209 | Resmed S8 Pioneer Cpap SystemSummary page 1…ronics REMstar Auto C-Flex CPAP System (K040101) Respironics REMstar M Series CPAP System (K052110) Respironics BiPAP Auto Bi-level System (K050759) Resmed S8 Pioneer (K041209) Modified design. 3/8/2007 Premarket Notification — Special 510(k) (4066 £30 510(K) SUMMARY OF SAFETY & EFFECTIVENESS MAR O… | 2004 |
What descends from it? (35)
See all 353 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 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K130077Remstar SERespironics, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 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 11 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 28 ancestors have a recall of any class.
- Of its descendants, K091319 (Respironics Inc., Sleep & Home Respiratory Group, 2009) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K052110.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Auto M-Series with AFLEX Series CPAP System delivers
positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in
spontaneously breathing patients weighing over 30kg.
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/K063830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063830: Remstar Aflex Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063830
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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