# K082979: S8 Advance

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jan 2, 2009 after 88 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: 6 generations back to K971260 (1997). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080079: S8 Escape II, Resmed, Ltd. (2008) Summary page 1.
- K041209: Resmed S8 Pioneer Cpap System, Resmed, Ltd. (2004) Summary page 2.

## Most influential descendants
- K112079: Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 (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 S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

Source page: https://510kreport.com/device/K082979
Methodology: https://510kreport.com/methodology