510(k) · Cleared
ClearedRes Traxx Online, Model: R14
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 Mar 20, 2009 as substantially equivalent to K070746 (Resmed, Ltd., 2007) after an 88-day review. Its family tree reaches back 6 generations to 1997. 13 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K971260 (1997). 10 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 5 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 4 generations backK030797 S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap…Resmed Corp · 2004
- 3 generations backK051314 Res Traxx Data CenterResmed, Ltd. · 2005
- 2 generations backK053205 Res Traxx Data CenterResmed, Ltd. · 2006
- 1 generation backK070746 Restraxx Data Centre, Model R10Resmed, Ltd. · 2007
- This deviceK083816 Res Traxx Online, Model: R14Resmed, Ltd. · 2009
- Descendant · cites it directly · 12 of its ownK093684 Easycare OnlineResmed, Ltd. · 2010
- Descendant · 2 generations on · 9 of its ownK123557 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 3 generations on · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
- Descendant · 4 generations on · 4 of its ownK152356 SapphireRespironics, Inc. · 2016
- Descendant · 5 generations on · 1 of its ownK181053 Care OrchestratorRespironics, Inc. · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K093684Easycare OnlineResmed, Ltd. · 2010 · cites it directly12descendants
- K123557Easycare OnlineResmed, Ltd. · 2013 · 2 generations on9descendants
- K132371Easycare OnlineResmed, Ltd. · 2013 · 3 generations on8descendants
- K152356SapphireRespironics, Inc. · 2016 · 4 generations on4descendants
- K181053Care OrchestratorRespironics, Inc. · 2019 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −5 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −4 | K030797 | S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with… | Resmed Corp | 2004 | — |
| −3 | K051314 | Res Traxx Data Center | Resmed, Ltd. | 2005 | — |
| −2 | K053205 | Res Traxx Data Center | Resmed, Ltd. | 2006 | — |
| −1 | K070746 | Restraxx Data Centre, Model R10 | Resmed, Ltd. | 2007 | — |
| 0 (this device) | K083816 | Res Traxx Online, Model: R14 | Resmed, Ltd. | 2009 | — |
| +1 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| +2 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +3 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| +4 | K152356 | Sapphire | Respironics, Inc. | 2016 | — |
| +5 | K181053 | Care Orchestrator | Respironics, Inc. | 2019 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K070746 | Restraxx Data Centre, Model R10Summary page 1…mmon/Usual Name Noncontinuous ventilator (IPPB), Proprietary Name ResTraxx Online Predicate Device(s) ResTraxx System (K070746) Reason for submission Change to Indications for Use 5th Dec, 2008… | 2007 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093684 | Easycare Online | 2010 | 12 |
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 12 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K093684 (Resmed, Ltd., 2010) has gone furthest, with 12 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. 2009, 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?
ResTraxx Online is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been wirelessly transmitted from the patient's flow generator located in the home to the care giver. ResTraxx Online also provides remote settings capabilities.
It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond, S8 Series CPAP Systems, VPAP III, VPAP III ST, VPAP Malibu, VPAP Auto, VPAP Auto 25, VPAP S and VPAP ST variants positive airway pressure flow generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083816: Res Traxx Online, Model: R14.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083816
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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