# K102513: S9 Vpap ST with H5I

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jan 5, 2011 after 126 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: 8 generations back to K971260 (1997). 27 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 39 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 2.
- K091947: S8 Aspen with H4I Plus, Resmed, Ltd. (2009) Summary page 1.
- K092186: Vpap TX, Resmed, Ltd. (2009) Summary page 1.

## Most influential descendants
- K113288: Vpap ST-a (2012), 7 descendants of its own
- K153061: Juno VPAP ST-A (2016), 3 descendants of its own
- K140159: S9 Wanda Vpap ST (2014), 2 descendants of its own
- K161492: Juno VPAP ST-A (2017), 1 descendant of its own
- K123511: S9 Vpap TX (2013), 1 descendant of its own

## Indications for use
The S9 VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The S9 VPAP ST is intended for use in the hospital and home.

Source page: https://510kreport.com/device/K102513
Methodology: https://510kreport.com/methodology