510(k) · Cleared
ClearedRXiBreeze PAP System (RXiBreeze 20C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resvent Medical Technology Co., Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 23, 2026 as substantially equivalent to K153387 (3B Medical, Inc., 2016) after a 304-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Jul 23, 2026
- Review
- 304 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K953930 (1996). 14 ancestors in all. No later device cites it as a predicate yet.
- 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 backK110629 Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier3B Products, Inc. · 2012
- 3 generations backK132967 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap3B Medical, Inc. · 2013
- 2 generations backK141770 Luna Cpap and Auto-Cpap System3B Medical, Inc. · 2015
- 1 generation backK153387 Luna CPAP and Auto CPAP System3B Medical, Inc. · 2016
- This deviceK253044 RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
View 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 | K110629 | Resmart Cpap, Resmart Auto-Cpap and Resmart Humidifier | 3B Products, Inc. | 2012 | — |
| −3 | K132967 | 3B Resmart Cpap and Auto Cpap, BMC Resmart Cpap and Auto Cpap | 3B Medical, Inc. | 2013 | — |
| −2 | K141770 | Luna Cpap and Auto-Cpap System | 3B Medical, Inc. | 2015 | — |
| −1 | K153387 | Luna CPAP and Auto CPAP System | 3B Medical, Inc. | 2016 | — |
| 0 (this device) | K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K153387 | Luna CPAP and Auto CPAP SystemSummary page 5…tinuous (Respirator) Regulation Number: 868.5905 Product Codes: BZD Regulatory Class: II 4. Predicate Device Information Predicate Device: K153387, Luna® CPAP System, Product Code BZD Reference Device: K211155, M1 Mini Auto CPAP System, Product Code BZD 5. Device Descriptio… | 2016 |
| † | K211155 | Auto CPAP System | 2022 |
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 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 14 ancestors has 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. 2026, 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 RXiBreeze™ PAP system delivers positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing adult patients. It is for single patient use in the home, hospital, or institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253044: RXiBreeze PAP System (RXiBreeze 20C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253044
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026