510(k) · Cleared
Cleared3B Resmart Bpap 25A, BMC Resmart Bpap 25A
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 Aug 25, 2014 as substantially equivalent to K050759 (Respironics, Inc., 2005) and 1 other predicate after a 257-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 25, 2014
- Review
- 257 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K953930 (1996). 24 ancestors in all, the oldest K961783 (1996). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 5 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 4 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 3 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 2 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 1 generation backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- This deviceK133769 3B Resmart Bpap 25A, BMC Resmart Bpap 25A3B Medical, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK201620 Luna® G3 BPAP 25A3B Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK213169 BPAP SystemBMC Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK212263 Luna G3 BPAP System3B Medical, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −6 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −5 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −4 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −3 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −2 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −1 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| 0 (this device) | K133769 | 3B Resmart Bpap 25A, BMC Resmart Bpap 25A | 3B Medical, Inc. | 2014 | — |
| +1 | K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021 | — |
| +2 | K213169 | BPAP System | BMC Medical Co., Ltd. | 2022 | — |
| +2 | K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K050759 | Bipap AutoSummary page 4…rence 21 CFR 868.5905 Product Code BZD –Non-continuous Ventilator (Respirator) Predicate Device(s) Predicate Respironics BiPAP Auto (K050759) Predicate RESmart® Auto-CPAP (K131707) Indications for Use The 3B and BMC RESmart® B… | 2005 |
| * | K131707 | 3B Resmart Cpap and Auto Cpap Systems, BMC Resmart Cpap and Auto Cpap SystemsSummary page 4…ntinuous Ventilator (Respirator) Predicate Device(s) Predicate Respironics BiPAP Auto (K050759) Predicate RESmart® Auto-CPAP (K131707) Indications for Use The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi- level… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201620 | Luna® G3 BPAP 25A | 2021 | 2 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K201620 (3B Medical, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K050759.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 3B and BMC RESmart BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional 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 >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133769 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133769: 3B Resmart Bpap 25A, BMC Resmart Bpap 25A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133769
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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