510(k) · Cleared
ClearedBreathePal Bilevel (GFM50-MD2201)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compal Electronics, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Mar 17, 2026 as substantially equivalent to K113053 (Respironics, Inc., 2012) after a 258-day review. Its family tree reaches back 11 generations to 1996. 7 of the 113 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 17, 2026
- Review
- 258 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K953930 (1996). 112 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 7 of the 113 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 deviceK252078 BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc. · 2026
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 deviceK252078 BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc. · 2026
Class I recalls in this family
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) | K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026 | — |
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 |
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.
7 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? (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 |
|---|---|---|---|
| * | K113053 | Bipap a 30 Ventilatory Support SystemSummary page 5…21 CFR 868.5895 Classification Name Continuous Ventilator Product Code MNS Primary Predicate Device BiPAP A30 Ventilatory support system (K113053) Device Description BreathePal Bilevel devices are blower-based positive airway pressure systems designed to provide non-invasi… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
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
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- 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
- 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
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 31 of the 112 ancestors have a recall of any class; 7 have a Class I recall.
- 1 other device also cites its predicate K113053.
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. 2026, 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 BreathePal Bilevel is intended to provide non-invasive ventilator (NIV) support for adult patients weighing over 30 kg (66lbs) who suffer from Obstructive Sleep Apnea (OSA) and Respiratory Impairment. It is intended for use in both home and clinical environment, including hospitals, sleep laboratories, and sub-acute care institutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252078: BreathePal Bilevel (GFM50-MD2201).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252078
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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