510(k) · Cleared
ClearedLuna G3 BPAP 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 Mar 25, 2022 as substantially equivalent to K201620 (3B Medical, Inc., 2021) after a 248-day review. Its family tree reaches back 12 generations to 1996. 3 of the 37 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 25, 2022
- Review
- 248 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K953930 (1996). 36 ancestors in all, the oldest K930656 (1994). No later device cites it as a predicate yet. 3 of the 37 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 deviceK212263 Luna G3 BPAP System3B Medical, Inc. · 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 deviceK212263 Luna G3 BPAP System3B Medical, Inc. · 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) | K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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.
3 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 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 12 of the 36 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K201620.
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?
The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212263: Luna G3 BPAP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212263
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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