# K030797: S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Mar 10, 2004 after 363 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: 2 generations back to K971260 (1997). 6 ancestors in all.
17 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)
- K013909: S7 Elite CP AP System, Resmed Corp (2002) Summary page 1.
- K013843: Autoset Spirit Cpap System, Resmed Corp (2002) Summary page 1.
- K014025: Hommed Sentry Iii Patient Monitor System with Card Reader, Hommed, LLC (2002) Summary page 1.
- K020184: Hommed Central Station, Hommed, LLC (2002) Summary page 1.

## Most influential descendants
- K051314: Res Traxx Data Center (2005), 16 descendants of its own
- K053205: Res Traxx Data Center (2006), 15 descendants of its own
- K070746: Restraxx Data Centre, Model R10 (2007), 14 descendants of its own
- K083816: Res Traxx Online, Model: R14 (2009), 13 descendants of its own
- K093684: Easycare Online (2010), 12 descendants of its own

## Indications for use
The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators. SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment. All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.

Source page: https://510kreport.com/device/K030797
Methodology: https://510kreport.com/methodology