# K032480: Autoset Spirit System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Oct 16, 2003 after 65 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). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013843: Autoset Spirit Cpap System, Resmed Corp (2002)

## Most influential descendants
- K083656: Apex Medical XT Auto Cpap 9S-005200 (2009), 4 descendants of its own
- K112079: Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 (2012), 2 descendants of its own
- K120035: Apex Medical Ich Cpap Series (9S-007XXX) (2012), 2 descendants of its own
- K141522: Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series (2014), 1 descendant of its own
- K150111: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (2015), 0 descendants of its own

## Indications for use
The AUTOSET SPIRIT self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The AUTOSET SPIRIT self-adjusting sleep apnea system has two treatment modes (auto-titrating and fixed-pressure CPAP). The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT self-adjusting sleep apnea System and HUMIDAIRE 2i are for home and hospital use.

Source page: https://510kreport.com/device/K032480
Methodology: https://510kreport.com/methodology