510(k) · Cleared
ClearedAuto CPAP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BMC Medical Co., Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 9, 2022 as substantially equivalent to K153387 (3B Medical, Inc., 2016) and 1 other predicate after a 324-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Mar 9, 2022
- Review
- 324 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913396 (1992). 55 ancestors in all, the oldest K905404 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations between
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK140124 S9 EloueraResmed Corp · 2014
- 1 generation backK160836 Menai SystemResmed, Ltd. · 2016
- This deviceK211155 Auto CPAP SystemBMC Medical Co., Ltd. · 2022
Show all 10 generations
- Root · 10 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 8 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 7 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 6 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 5 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 4 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 3 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 2 generations backK140124 S9 EloueraResmed Corp · 2014
- 1 generation backK160836 Menai SystemResmed, Ltd. · 2016
- This deviceK211155 Auto CPAP SystemBMC Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −9 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −8 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −7 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −6 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −5 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −4 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −3 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −2 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| −1 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| 0 (this device) | K211155 | Auto CPAP System | BMC Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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.
Planning a device in BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 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 |
|---|---|---|---|
| * | K153387 | Luna CPAP and Auto CPAP SystemSummary page 4…oducts Code BZD Medical Specialties Anesthesiology Predicate Device(s) Luna CPAP and Auto CPAP System (K153387) Menai System (K160836) 1 === Page 5 =… | 2016 |
| * | K160836 | Menai SystemSummary page 4…Anesthesiology Predicate Device(s) Luna CPAP and Auto CPAP System (K153387) Menai System (K160836) 1 Traditional 510(K) Premarket Submission… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K153387.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home. Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use. LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also…
Read the full statement (113 words)
Auto CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home.
Auto CPAP System is for prescription use only. It is a travel CPAP device intended for single-patient use.
LightTrip App is a mobile application for patients to remotely operate BMC Mini serial devices, and transmit, store and display usage and treatment information. It can also receive parameters and device firmware upgrade data from the cloud, and then transmit these data to the device. The LightTrip app also allows healthcare professionals to remotely configure compatible OSA therapy devices. LightTrip App is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211155: Auto CPAP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211155
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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