# K090248: Bipap Autosv

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Mar 4, 2009 after 30 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 4 (4 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). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 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.
- K020777: Bipap Synchrony Ventilatory Support System with BI-Flex, Respironics, Inc. (2002) Summary page 1.

## Recalls of this device
- Aug 26, 2022 · Class I · Z-1659-2022: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Aug 26, 2022 · Class I · Z-1657-2022: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Aug 26, 2022 · Class I · Z-1655-2022: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
- Jun 14, 2021 · Class I · Z-1973-2021: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain c

## 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/K090248
Methodology: https://510kreport.com/methodology