# K033841: Resmed S8 Prime Cpap System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Mar 10, 2004 after 91 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: 3 generations back to K971260 (1997). 6 ancestors in all.
100 later devices descend from it; 4 cite it directly.
12 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024191: S7 Elite and Autoset Spirit Cpap Systems with Reslink, Resmed, Ltd. (2003) Summary page 1.
- K930656: Sullivan Iii Nasal Cpap System, Rescare, Ltd. (1994) Summary page 1.

## Most influential descendants
- K041209: Resmed S8 Pioneer Cpap System (2004), 96 descendants of its own
- 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

## 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 Prime CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Prime CPAP System is intended for home and hospital use.

Source page: https://510kreport.com/device/K033841
Methodology: https://510kreport.com/methodology