# K041209: Resmed S8 Pioneer Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jul 1, 2004 after 52 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971260 (1997). 9 ancestors in all.
96 later devices descend from it; 6 cite it directly.
12 of 106 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) Summary page 1.
- K033841: Resmed S8 Prime Cpap System, Resmed, Ltd. (2004) Summary page 1.
- K030843: Vpap Iii, Resmed, Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
- K082605: Vpap Auto with Humidaire 3I (2009), 33 descendants of its own
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1006-2007: S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failur

## Indications for use
The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP). The S8 Pioneer system is intended for home and hospital use.

Source page: https://510kreport.com/device/K041209
Methodology: https://510kreport.com/methodology