510(k) · Cleared
Recalled · Class I · 2024Remstar Auto a-Flex HT
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 Dec 16, 2011 as substantially equivalent to K091319 (Respironics Inc., Sleep & Home Respiratory Group, 2009) after a 60-day review. Its family tree reaches back 9 generations to 1996. 5 of the 40 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Dec 16, 2011
- Review
- 60 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 9 generations to K953930 (1996). 30 ancestors in all, the oldest K930656 (1994). 9 later devices descend from it, 3 citing it directly. 5 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 5 generations between
- 3 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 2 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 1 generation backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- This deviceK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK131982 Remstar Auto a-Flex HTRespironics, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK122769 Remstar SERespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK201620 Luna® G3 BPAP 25A3B Medical, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK130077 Remstar SERespironics, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK200480 DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 8 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 7 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 6 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 5 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 4 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 3 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 2 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 1 generation backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- This deviceK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · cites it directly5descendants
- K122769Remstar SERespironics, Inc. · 2012 · cites it directly3descendants
- K201620Luna® G3 BPAP 25A3B Medical, Inc. · 2021 · 2 generations on2descendants
- K130077Remstar SERespironics, Inc. · 2013 · 2 generations on2descendants
- K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −8 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −7 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −6 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −5 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −4 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −3 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −2 | 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 |
| 0 (this device) | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | — |
| +1 | K131982 | Remstar Auto a-Flex HT | Respironics, Inc. | 2013 | Class I |
| +1 | K122769 | Remstar SE | Respironics, Inc. | 2012 | Class I |
| +2 | K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021 | — |
| +2 | K130077 | Remstar SE | Respironics, Inc. | 2013 | Class I |
| +2 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020 | — |
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 |
|---|---|---|
| 2012 | 1 | 1 |
| 2013 | 2 | 2 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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.
5 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 |
|---|---|---|---|
| * | K091319 | Remstar Auto a-FlexSummary page 1…entilator, non-continuous (respirator) (21 CFR 868.5905, Product Code BZD) Predicate Device(s) REMstar Auto A-Flex (K(091319) Reason for Submission .The REMstar Auto A-Flex HT isthe result of modifications made… | 2009 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2024 | Class I | Z-1817-2024 | Device Design | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death. |
| 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.
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K122769Remstar SERespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130077Remstar SERespironics, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 10 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131982 (Respironics, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K091319.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Auto A-Flex HT 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/K113068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113068: Remstar Auto a-Flex HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113068
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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