# K030843: Vpap Iii

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Aug 15, 2003 after 151 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: 2 generations back to K971260 (1997). 4 ancestors in all.
106 later devices descend from it; 3 cite it directly.
13 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013909: S7 Elite CP AP System, Resmed Corp (2002) Summary page 1.
- K961783: Sullivan Vpap II ST Nasal Vpap System, Resmed, Ltd. (1996) Summary page 1.

## Most influential descendants
- K041209: Resmed S8 Pioneer Cpap System (2004), 96 descendants of its own
- K062291: Vpap Malibu with H2I (2006), 41 descendants of its own
- K071171: Vpap Auto with H3I (2007), 40 descendants of its own
- K080131: Vpap ST (2008), 38 descendants of its own
- K063830: Remstar Aflex Cpap System (2007), 35 descendants of its own

## Indications for use
The VPAP III™ is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE 2i™) is indicated for the humidification and warming of air from the VPAP III™ flow generator. The VPAP III™ flow generator and HUMIDAIRE 2i™ are for home and hospital use.

Source page: https://510kreport.com/device/K030843
Methodology: https://510kreport.com/methodology