# K082605: Vpap Auto with Humidaire 3I

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Jan 13, 2009 after 127 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). 19 ancestors in all.
33 later devices descend from it; 2 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)
- K071171: Vpap Auto with H3I, Resmed, Ltd. (2007) Summary page 1.
- K041900: HC604 Cpap Humidifier, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K091947: S8 Aspen with H4I Plus (2009), 31 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
- K160836: Menai System (2016), 6 descendants of its own

## Indications for use
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.

Source page: https://510kreport.com/device/K082605
Methodology: https://510kreport.com/methodology