510(k) · Cleared
Recalled · Class I · 2025Bipap a 40 Ventilatory Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Dec 14, 2012 as substantially equivalent to K113053 (Respironics, Inc., 2012) and 1 other predicate after a 196-day review. Its family tree reaches back 11 generations to 1996. 13 of the 138 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 3 times, including 3 Class I recalls.
- Decided
- Dec 14, 2012
- Review
- 196 days
- Class
- Class II
- Product code
- MNT
- Recalls
- 3 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 11 generations to K953930 (1996). 131 ancestors in all, the oldest K811102 (1981). 6 later devices descend from it, 1 citing it directly. 13 of the 138 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 7 generations between
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 1 generation backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK233452 Vivo 45 LSBreas Medical AB · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK241135 RESPOND (R) VentilatorCorvent Medical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 10 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 9 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 8 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 7 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 6 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 5 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 4 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 1 generation backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- This deviceK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K181166Trilogy EvoRespironics, Inc. · 2019 · cites it directly5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 2 generations on0descendants
- K233452Vivo 45 LSBreas Medical AB · 2025 · 3 generations on0descendants
- K241135RESPOND (R) VentilatorCorvent Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −10 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −9 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −8 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −7 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −6 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −5 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −3 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −2 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −1 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| 0 (this device) | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | — |
| +1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +2 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +2 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
| +3 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 1 |
| +2 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 15 | 2 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 1 |
| 2003 | 8 | 1 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 2 |
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
13 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 MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 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 |
|---|---|---|---|
| * | K113053 | Bipap a 30 Ventilatory Support SystemSummary page 2…A40 Ventilatory Support System Predicate Device Namne(s) and 5 10(k) & BiPAP A30 Ventilatory Support System numbers: (K1 13053) 0Trilogy 200 Ventilatory Support System… | 2012 |
| * | K093416 | Trilogy 200 VentilatorSummary page 3…h Bi-Flex or the AVAPS therapy features available if enabled by the health care professional. The secondary device predicate, the Trilogy 200 was previously cleared in K093416. Similar to the Trilogy 200, the BiPAP A40 can provide pressure up to 40cm, provide invasive support if prescribed, be used in mo… | 2010 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181166 | Trilogy Evo Class I | 2019 | 5 |
Has anything in its family been recalled? (13 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2025 | Class I | Z-2037-2025 | Device Design | This device does not indicate for use in patients with respiratory failure. |
| 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-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. |
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.
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 6 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 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 2 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 12; 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 1.4 years on median.
- 41 of the 131 ancestors have a recall of any class; 10 have a Class I recall.
- Of its descendants, K181166 (Respironics, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K113053.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | 0 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BiPAP A40 ventilator is intended to provide invasive and non-invasive ventilatory support to treat adult and pediatric patients weighing over 10 kg (22 Ibs) with Obstructive Sleep Apnea (GSA), Respiratory Insufficiency, or Respiratory Failure. It is intended to be used in the home, institutional/hospital, and portable applications such as wheelchairs and gurneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121623: Bipap a 40 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/K121623
Report an extraction error
Are you the manufacturer?
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