510(k) · Cleared
Recalled · Class I · 2025Bipap a 30 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 Feb 1, 2012 as substantially equivalent to K092818 (Respironics, Inc., 2010) and 2 other predicates after a 111-day review. Its family tree reaches back 10 generations to 1996. 10 of the 120 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 5 times, including 5 Class I recalls.
- Decided
- Feb 1, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 5 (5 Class I)
- Predicates
- 3
Its longest line of descent runs back 10 generations to K953930 (1996). 111 ancestors in all, the oldest K811102 (1981). 8 later devices descend from it, 2 citing it directly. 10 of the 120 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 deviceK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK252078 BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
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 deviceK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · cites it directly6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on2descendants
- K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc. · 2026 · cites it directly0descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 3 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 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| 0 (this device) | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | — |
| +1 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +3 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +1 | K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026 | — |
| +3 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 12 | 2 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 1 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 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.
10 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…m Predicate Device Name(s) and a BiPAP C Series Ventilatory Support System 5 10O(k) numbers: (K0928 18) * V60 Ventilator… | 2010 |
| * | K082660 | V60 Ventilator, Model V8000Summary page 2…(K0928 18) * V60 Ventilator (K082660) * ResMed Stellar 150/100 ____ ___ _… | 2009 |
| * | K103167 | Stellar 150Summary page 2…* ResMed Stellar 150/100 ____ ___ ____ ____ ___ ____ ___(K 103 167) Reason for submission: Device modifications and additionalacesrs… | 2011 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2025 | Class I | Z-2036-2025 | Device Design | This device does not indicate for use in patients with respiratory failure. |
| Aug 26, 2022 | Class I | Z-1654-2022 | Process control | Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. |
| Jun 14, 2021 | Class I | Z-1957-2021 | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
| Jun 14, 2021 | Class I | Z-1958-2021 | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
| 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
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Direct predicate · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 30 of the 111 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K121623 (Respironics, Inc., 2012) has gone furthest, with 6 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. 2012, 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 BiPAP A30 ventilator is intended to provide non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (221bs) with Obstructive Sleep Apnea (OSA and Respiratory Insufficiency. It is intended to be used in both the home and clinical settings, such as hospitals, sleep laboratories, and sub-acute care institutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113053: Bipap a 30 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/K113053
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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