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 Mar 24, 2011 as substantially equivalent to K092818 (Respironics, Inc., 2010) and 2 other predicates after a 209-day review. Its family tree reaches back 10 generations to 1996. 4 of the 44 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 24, 2011
- Review
- 209 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 1 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 10 generations to K953930 (1996). 42 ancestors in all, the oldest K833786 (1983). 1 later device descends from it, 1 citing it directly. 4 of the 44 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 backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- This deviceK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK111378 Oximetry Interface KitPhilips Respironics, Inc. · 2011 · Recalled (Class I)
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 backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- This deviceK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · cites it directly0descendants
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 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| 0 (this device) | K102465 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2011 | — |
| +1 | K111378 | Oximetry Interface Kit | Philips 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 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
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.
4 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? (3)
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 |
|---|---|---|---|
| * | K092818 | Bipap Avaps Ventilatory Support SystemSummary page 2…tem Predicate Device Namne(s) and 5 10(k) I1. Respironics BiPAP AVAPS Ventilatory numbers: Support System (cleared under K0928188- date of concurrence: January 22, 2010).… | 2010 |
| * | K082209 | Devilbiss DV5M Smartlink SystemSummary page 2…nce: January 22, 2010). 2. DeVilbiss DV5M SmartLink System (cleared under K082209 - date of concurrence: October 28, 2008).… | 2008 |
| * | K024191 | S7 Elite and Autoset Spirit Cpap Systems with ReslinkSummary page 2…S7 Elite and AutoSet Spirit CPAP Systems with ResLink (cleared under K024191 - date of concurrence: July 7, 2003). Reason for submission:… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111378 | Oximetry Interface Kit Class I | 2011 | 0 |
Has anything in its family been recalled? (4 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.
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ on the line of descent in 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
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 12 of the 42 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K111378 (Philips Respironics, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092818.
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. 2011, 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 Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series therapy devices (BiPAP AVAPS and BiPAP SIT) to measure functional oxygen saturation of arterial hemoglobin (%SpO 2 ) and pulse rate for adult and pediatric patients. The Oximetry Module may be used in a hospital or home care environment.
The Respironics BiPAP C Series 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 C Series Ventilatory System may be used in the hospital or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102465: Bipap Avaps Ventilatory Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102465
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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