510(k) · Cleared
ClearedRes Traxx Data Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 3, 2006 as substantially equivalent to K051314 (Resmed, Ltd., 2005) after a 79-day review. Its family tree reaches back 4 generations to 1997. 15 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 79 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K971260 (1997). 8 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 3 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 2 generations backK030797 S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap…Resmed Corp · 2004
- 1 generation backK051314 Res Traxx Data CenterResmed, Ltd. · 2005
- This deviceK053205 Res Traxx Data CenterResmed, Ltd. · 2006
- Descendant · cites it directly · 14 of its ownK070746 Restraxx Data Centre, Model R10Resmed, Ltd. · 2007
- Descendant · 2 generations on · 13 of its ownK083816 Res Traxx Online, Model: R14Resmed, Ltd. · 2009
- Descendant · 3 generations on · 12 of its ownK093684 Easycare OnlineResmed, Ltd. · 2010
- Descendant · 4 generations on · 9 of its ownK123557 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 5 generations on · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K070746Restraxx Data Centre, Model R10Resmed, Ltd. · 2007 · cites it directly14descendants
- K083816Res Traxx Online, Model: R14Resmed, Ltd. · 2009 · 2 generations on13descendants
- K093684Easycare OnlineResmed, Ltd. · 2010 · 3 generations on12descendants
- K123557Easycare OnlineResmed, Ltd. · 2013 · 4 generations on9descendants
- K132371Easycare OnlineResmed, Ltd. · 2013 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −3 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −2 | K030797 | S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with… | Resmed Corp | 2004 | — |
| −1 | K051314 | Res Traxx Data Center | Resmed, Ltd. | 2005 | — |
| 0 (this device) | K053205 | Res Traxx Data Center | Resmed, Ltd. | 2006 | — |
| +1 | K070746 | Restraxx Data Centre, Model R10 | Resmed, Ltd. | 2007 | — |
| +2 | K083816 | Res Traxx Online, Model: R14 | Resmed, Ltd. | 2009 | — |
| +3 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| +4 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +5 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K051314 | Res Traxx Data CenterSummary page 1…continuous ventilator (IPPB). Proprietary Name ResTraxx Data Center System Predicate Device(s) ResTraxx Data Center System (K051314) Reason for submission Additional Indications Indications for Use The ResTraxx Data Center system is inte… | 2005 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070746 | Restraxx Data Centre, Model R10 | 2007 | 14 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070746 (Resmed, Ltd., 2007) has gone furthest, with 14 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.
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 ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.
It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond, VPAP III & S8 Series CPAP Systems, positive airway pressure flow generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053205: Res Traxx Data Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053205
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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