# K090539: Bipap Autosv Advanced

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Oct 30, 2009 after 245 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962517 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063540: Bipap Autosv, Respironics, Inc. (2007) Summary page 1.
- K063533: Bipap Synchrony, Respironics, Inc. (2007) Summary page 1.

## Recalls of this device
- Apr 1, 2024 · Class I · Z-1817-2024: Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insuffi
- Aug 26, 2022 · Class I · Z-1658-2022: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

## Indications for use
The BiPAP AutoSV Advanced is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Source page: https://510kreport.com/device/K090539
Methodology: https://510kreport.com/methodology