# K062291: Vpap Malibu with H2I

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Sep 8, 2006 after 32 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: 3 generations back to K971260 (1997). 6 ancestors in all.
41 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030843: Vpap Iii, Resmed, Ltd. (2003) Summary page 1.
- K013843: Autoset Spirit Cpap System, Resmed Corp (2002) Summary page 2.

## Most influential descendants
- K071171: Vpap Auto with H3I (2007), 40 descendants of its own
- K080131: Vpap ST (2008), 38 descendants of its own
- K082605: Vpap Auto with Humidaire 3I (2009), 33 descendants of its own
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own
- K092186: Vpap TX (2009), 18 descendants of its own

## Indications for use
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA). It is intended for use in the hospital and home.

Source page: https://510kreport.com/device/K062291
Methodology: https://510kreport.com/methodology