# K063540: Bipap Autosv

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Feb 22, 2007 after 90 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962517 (1997). 12 ancestors in all.
13 later devices descend from it; 3 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992530: Bipap Synchrony HC, Respironics, Inc. (2000) Summary page 1.
- K012323: Bipap Synchrony Ventilatory Support System, Respironics, Inc. (2001) Summary page 1.
- K031656: Bipap Harmony Ventilatory Support System, Respironics, Inc. (2003) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.
- K051364: Vpap Adapt, Resmed, Ltd. (2005) Summary page 2.

## Most influential descendants
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K111549: Attune Sleep Apnea System (2012), 5 descendants of its own
- K122130: Winx Sleep Therapy System (2012), 3 descendants of its own
- K090398: Provent Professional Sleep Apnea Therapy (2009), 3 descendants of its own
- K130538: Winx Sleep Therapy System (2013), 2 descendants of its own

## Indications for use
The BiPAP AutoSV 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/K063540
Methodology: https://510kreport.com/methodology