# K080131: Vpap ST

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Apr 1, 2008 after 74 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.
38 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062291: Vpap Malibu with H2I, Resmed, Ltd. (2006) Summary page 1.
- K041209: Resmed S8 Pioneer Cpap System, Resmed, Ltd. (2004) Summary page 1.
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.
- K071171: Vpap Auto with H3I, Resmed, Ltd. (2007) Summary page 1.

## Most influential descendants
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own
- K092186: Vpap TX (2009), 18 descendants of its own
- 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

## Indications for use
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.

Source page: https://510kreport.com/device/K080131
Methodology: https://510kreport.com/methodology