510(k) · Cleared
ClearedLuna CPAP and Auto CPAP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3B Medical, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 8, 2016 as substantially equivalent to K141770 (3B Medical, Inc., 2015) after a 290-day review. Its family tree reaches back 6 generations to 1996. 2 later devices descend from it.
- Decided
- Sep 8, 2016
- Review
- 290 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953930 (1996). 13 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 5 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 4 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 3 generations backK110629 Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc. · 2012
- 2 generations backK132967 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc. · 2013
- 1 generation backK141770 Luna Cpap and Auto-Cpap System3B Medical, Inc. · 2015
- This deviceK153387 Luna CPAP and Auto CPAP System3B Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK253044 RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK211155 Auto CPAP SystemBMC Medical Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −5 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −4 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −3 | K110629 | Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier | 3B Products, Inc. | 2012 | — |
| −2 | K132967 | 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap | 3B Medical, Inc. | 2013 | — |
| −1 | K141770 | Luna Cpap and Auto-Cpap System | 3B Medical, Inc. | 2015 | — |
| 0 (this device) | K153387 | Luna CPAP and Auto CPAP System | 3B Medical, Inc. | 2016 | — |
| +1 | K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026 | — |
| +1 | K211155 | Auto CPAP System | BMC Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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.
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? (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 |
|---|---|---|---|
| * | K141770 | Luna Cpap and Auto-Cpap SystemSummary page 5…st, Shijingshan Beijing, CHINA 100043 Class II Device Non-continuous ventilator Medical Device 21 CFR 868.5905 BZD Anesthesiology Luna® CPAP and Auto-CPAP Systems (K141770) Device Modification The Luna® CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstru… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K253044 (Resvent Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Luna® CPAP and Auto CPAP System are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated heated humidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153387: Luna CPAP and Auto CPAP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153387
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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