510(k) · Cleared
Recalled · Class I · 2025Remstar 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 Oct 18, 2013 as substantially equivalent to K113068 (Respironics, Inc., 2011) after a 112-day review. Its family tree reaches back 10 generations to 1996. 3 of the 37 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- Oct 18, 2013
- Review
- 112 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 5 (5 Class I)
- Predicates
- 1
Its longest line of descent runs back 10 generations to K953930 (1996). 31 ancestors in all, the oldest K930656 (1994). 5 later devices descend from it, 2 citing it directly. 3 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations between
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 1 generation backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK131982 Remstar Auto a-Flex HTRespironics, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK201620 Luna® G3 BPAP 25A3B Medical, Inc. · 2021
- 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
- Descendant · 2 generations on · 0 of its ownK213169 BPAP SystemBMC Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212263 Luna G3 BPAP System3B Medical, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 8 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 7 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 6 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 5 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 4 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 1 generation backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK131982 Remstar Auto a-Flex HTRespironics, Inc. · 2013
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K201620Luna® G3 BPAP 25A3B Medical, Inc. · 2021 · cites it directly2descendants
- K200480DreamStation 2 System, DreamStation 2 Advanced SystemRespironics, Inc. · 2020 · cites it directly1descendant
- K251770SleepRes PAP SystemSleepres, Inc. · 2025 · 2 generations on0descendants
- K213169BPAP SystemBMC Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K212263Luna G3 BPAP System3B Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −9 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −8 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −7 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −6 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −5 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −4 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −2 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −1 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K131982 | Remstar Auto a-Flex HT | Respironics, Inc. | 2013 | — |
| +1 | K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021 | — |
| +1 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020 | — |
| +2 | K251770 | SleepRes PAP System | Sleepres, Inc. | 2025 | — |
| +2 | K213169 | BPAP System | BMC Medical Co., Ltd. | 2022 | — |
| +2 | K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022 | — |
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 |
|---|---|---|
| 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.
3 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 |
|---|---|---|---|
| * | K113068 | Remstar Auto a-Flex HTSummary page 1…(respirator) (21 CFR 868.5905, Product Code BZD) Predicate Device(s) Respironics REMstar Auto A-Flex HT [K(113068) Reason for Submission The REMstar Auto A-Flex HT isthe result of modifications made… | 2011 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2025 | Class I | Z-2227-2025 | Process control | Devices may possess a programming error resulting in an incorrect device configuration. |
| Jun 30, 2025 | Class I | Z-2229-2025 | Process control | Devices may possess a programming error resulting in an incorrect device configuration. |
| Jun 30, 2025 | Class I | Z-2228-2025 | Process control | Devices may possess a programming error resulting in an incorrect device configuration. |
| Feb 10, 2023 | Class I | Z-1322-2023 | Software design (manufacturing process) | A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to download prescription… |
| 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.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 11 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K201620 (3B Medical, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K113068.
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 Auto A-Flex i-T 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/K131982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131982: 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/K131982
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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