# K013909: S7 Elite CP AP System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Jul 8, 2002 after 224 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: 1 generation back to K971260 (1997). 2 ancestors in all.
128 later devices descend from it; 7 cite it directly.
13 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980721: Sullivan Autoset, Resmed, Ltd. (1998) Summary page 1.
- K971260: Sullivan Humidaire Heated Humidifier, Resmed Corp (1997) Summary page 1.

## Most influential descendants
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink (2003), 110 descendants of its own
- K030843: Vpap Iii (2003), 106 descendants of its own
- K033841: Resmed S8 Prime Cpap System (2004), 100 descendants of its own
- K041209: Resmed S8 Pioneer Cpap System (2004), 96 descendants of its own
- K062291: Vpap Malibu with H2I (2006), 41 descendants of its own

## Indications for use
The S7TM EL~TECPAP System is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIREQ2ITM) is indicated for the humidification and warming of air from the S7 Elite flow generator device. The S7 ELITE CPAP flow generator and HUMIDAIRE 21 are for home and hospital use.

Source page: https://510kreport.com/device/K013909
Methodology: https://510kreport.com/methodology