510(k) · Cleared

Cleared

Restraxx Data Centre, Model R10

K070746510(k) TraditionalCleared Jul 13, 2007116-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 13, 2007 as substantially equivalent to K053205 (Resmed, Ltd., 2006) after a 116-day review. Its family tree reaches back 5 generations to 1997. 14 later devices descend from it.

Decided: Jul 13, 2007
Review: 116 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K971260 (1997). 9 ancestors in all. 14 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
4 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
3 generations backK030797 S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap…Resmed Corp · 2004
2 generations backK051314 Res Traxx Data CenterResmed, Ltd. · 2005
1 generation backK053205 Res Traxx Data CenterResmed, Ltd. · 2006
This deviceK070746 Restraxx Data Centre, Model R10Resmed, Ltd. · 2007
Descendant · cites it directly · 13 of its ownK083816 Res Traxx Online, Model: R14Resmed, Ltd. · 2009
Descendant · 2 generations on · 12 of its ownK093684 Easycare OnlineResmed, Ltd. · 2010
Descendant · 3 generations on · 9 of its ownK123557 Easycare OnlineResmed, Ltd. · 2013
Descendant · 4 generations on · 8 of its ownK132371 Easycare OnlineResmed, Ltd. · 2013
Descendant · 5 generations on · 4 of its ownK152356 SapphireRespironics, Inc. · 2016

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2009high 3 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 14 · See all

K083816Res Traxx Online, Model: R14Resmed, Ltd. · 2009 · cites it directly13descendants
K093684Easycare OnlineResmed, Ltd. · 2010 · 2 generations on12descendants
K123557Easycare OnlineResmed, Ltd. · 2013 · 3 generations on9descendants
K132371Easycare OnlineResmed, Ltd. · 2013 · 4 generations on8descendants
K152356SapphireRespironics, Inc. · 2016 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K971260	Sullivan Humidaire Heated Humidifier	Resmed Corp	1997	—
−4	K013909	S7 Elite CP AP System	Resmed Corp	2002	—
−3	K030797	S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with…	Resmed Corp	2004	—
−2	K051314	Res Traxx Data Center	Resmed, Ltd.	2005	—
−1	K053205	Res Traxx Data Center	Resmed, Ltd.	2006	—
0 (this device)	K070746	Restraxx Data Centre, Model R10	Resmed, Ltd.	2007	—
+1	K083816	Res Traxx Online, Model: R14	Resmed, Ltd.	2009	—
+2	K093684	Easycare Online	Resmed, Ltd.	2010	—
+3	K123557	Easycare Online	Resmed, Ltd.	2013	—
+4	K132371	Easycare Online	Resmed, Ltd.	2013	—
+5	K152356	Sapphire	Respironics, Inc.	2016	—

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
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

FIG. 1 — Lineage of K070746, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K053205	Res Traxx Data Center Summary page 1 …ommon/Usual Name Noncontinuous ventilator (IPPB). Proprietary Name ResTraxx System Predicate Device(s) ResTraxx Data Center (K053205) Reason for submission Change to Indications for Use…	Resmed, Ltd.	2006	—
†	K062291	Vpap Malibu with H2I	Resmed, Ltd.	2006	—

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K083816	Res Traxx Online, Model: R14	Resmed, Ltd.	2009	13

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 10 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K083816 (Resmed, Ltd., 2009) has gone furthest, with 13 descendants of its own.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)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 System 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 home to the care giver.

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 II ST and VPAP Malibu positive airway pressure

flow generators.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070746 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070746: Restraxx Data Centre, Model R10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070746

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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