510(k) · Cleared
ClearedBPAP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BMC Medical Co., Ltd. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Dec 5, 2022 as substantially equivalent to K153061 (Resmed, Ltd., 2016) and 1 other predicate after a 433-day review. Its family tree reaches back 12 generations to 1996. 6 of the 123 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 5, 2022
- Review
- 433 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K953930 (1996). 122 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 6 of the 123 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 8 generations between
- 3 generations backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- 2 generations backK131982 Remstar Auto a-Flex HTRespironics, Inc. · 2013 · Recalled (Class I)
- 1 generation backK201620 Luna® G3 BPAP 25A3B Medical, Inc. · 2021
- This deviceK213169 BPAP SystemBMC Medical Co., Ltd. · 2022
Show all 12 generations
- Root · 12 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 11 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 10 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 9 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 8 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 7 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 6 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 5 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 4 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 3 generations backK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
- 2 generations backK131982 Remstar Auto a-Flex HTRespironics, Inc. · 2013 · Recalled (Class I)
- 1 generation backK201620 Luna® G3 BPAP 25A3B Medical, Inc. · 2021
- This deviceK213169 BPAP SystemBMC Medical Co., Ltd. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −11 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −10 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −9 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −8 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −7 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −6 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −5 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −4 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −3 | K113068 | Remstar Auto a-Flex HT | Respironics, Inc. | 2011 | Class I |
| −2 | K131982 | Remstar Auto a-Flex HT | Respironics, Inc. | 2013 | Class I |
| −1 | K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021 | — |
| 0 (this device) | K213169 | BPAP System | BMC Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 12 | 2 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 1 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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.
6 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 |
|---|---|---|---|
| * | K153061 | Juno VPAP ST-ASummary page 6…zed by the user prior to use. The proposed device can be reused by single patient and multi-patients 5. Identification of Predicate Device 510(k) Number: K153061 Product Name: Juno VPAP ST-A 6. Identification of Secondary Predicate Device 510(k) Number: K201620 Product… | 2016 |
| * | K201620 | Luna® G3 BPAP 25ASummary page 6…ntification of Predicate Device 510(k) Number: K153061 Product Name: Juno VPAP ST-A 6. Identification of Secondary Predicate Device 510(k) Number: K201620 Product Name: Luna○ R G3 BPAP 25A 7. Non-Clinical Test Conclusion Non clinical tests were… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 28 of the 122 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K153061.
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. 2022, 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 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213169: BPAP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213169
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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