510(k) · Cleared
Recalled · Class I · 2021Bipap Avaps Ventilatory Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Jan 22, 2010 as substantially equivalent to K071509 (Respironics Inc., Sleep & Home Respiratory Group, 2007) and 1 other predicate after a 130-day review. Its family tree reaches back 9 generations to 1996. 8 of the 52 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 22, 2010
- Review
- 130 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 9 generations to K953930 (1996). 40 ancestors in all, the oldest K833786 (1983). 11 later devices descend from it, 3 citing it directly. 8 of the 52 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 deviceK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Recalled (Class I)
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 deviceK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · cites it directly8descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on2descendants
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · cites it directly1descendant
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) | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | — |
| +1 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +2 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +4 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K102465 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 2 |
| 2012 | 2 | 2 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
8 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 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 |
|---|---|---|---|
| * | K071509 | Bipap Synchrony 2 Ventilatory Support SystemSummary page 1…AP AVAPS Ventilatory Support System Predicate Device(s) Respironics BIPAP Synchrony 2 Ventilatory Support System (K071 509) Respironics REMstar 0 Series Auto with AFLEX CPAP System… | 2007 |
| * | K091319 | Remstar Auto a-FlexSummary page 2…sitive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091 319. The same ventilation modalities and therapy features, previously cleared in K071 509 is also included inthe BiPAP AVAP… | 2009 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2021 | Class I | Z-1973-2021 | 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
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 40 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K113053 (Respironics, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K071509.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The Respironics BiPAP AVAPS Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 Ibs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP AVAPS Ventilatory System may be used in the hospital or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092818: Bipap Avaps Ventilatory Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092818
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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