# K013843: Autoset Spirit Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Jul 16, 2002 after 238 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.
125 later devices descend from it; 7 cite it directly.
12 of 128 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
- 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
- K071171: Vpap Auto with H3I (2007), 40 descendants of its own

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

Source page: https://510kreport.com/device/K013843
Methodology: https://510kreport.com/methodology