# K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 2, 2003 after 194 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). 4 ancestors in all.
110 later devices descend from it; 5 cite it directly.
12 of 115 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)

## Most influential descendants
- K033841: Resmed S8 Prime Cpap System (2004), 100 descendants of its own
- K041209: Resmed S8 Pioneer Cpap System (2004), 96 descendants of its own
- K071171: Vpap Auto with H3I (2007), 40 descendants of its own
- K080131: Vpap ST (2008), 38 descendants of its own
- K063830: Remstar Aflex Cpap System (2007), 35 descendants of its own

## Indications for use
The S7 Elite and AUTOSET@SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the S7 Elite or AUTOSET@SPIRIT flow generator device. The S7 Elite and AUTOSET@SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

Source page: https://510kreport.com/device/K024191
Methodology: https://510kreport.com/methodology
