# K091947: S8 Aspen with H4I Plus

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Sep 28, 2009 after 90 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: 7 generations back to K971260 (1997). 21 ancestors in all.
31 later devices descend from it; 6 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080131: Vpap ST, Resmed, Ltd. (2008) Summary page 1.
- K082605: Vpap Auto with Humidaire 3I, Resmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- K102513: S9 Vpap ST with H5I (2011), 11 descendants of its own
- K140124: S9 Elouera (2014), 8 descendants of its own
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K160836: Menai System (2016), 6 descendants of its own
- K102586: S9 Vpap Adapt with H5I (2011), 6 descendants of its own

## Indications for use
The S8 Aspen self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S8 Aspen self-adjusting system is intended for home and hospital use.

Source page: https://510kreport.com/device/K091947
Methodology: https://510kreport.com/methodology