# K070746: Restraxx Data Centre, Model R10

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 13, 2007 after 116 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971260 (1997). 9 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053205: Res Traxx Data Center, Resmed, Ltd. (2006) Summary page 1.

## Most influential descendants
- K083816: Res Traxx Online, Model: R14 (2009), 13 descendants of its own
- K093684: Easycare Online (2010), 12 descendants of its own
- K123557: Easycare Online (2013), 9 descendants of its own
- K132371: Easycare Online (2013), 8 descendants of its own
- K152356: Sapphire (2016), 4 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K070746
Methodology: https://510kreport.com/methodology