# K092818: Bipap Avaps Ventilatory Support System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 22, 2010 after 130 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K953930 (1996). 40 ancestors in all.
11 later devices descend from it; 3 cite it directly.
8 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071509: Bipap Synchrony 2 Ventilatory Support System, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K091319: Remstar Auto a-Flex, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 2.

## Most influential descendants
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own
- K121623: Bipap a 40 Ventilatory Support System (2012), 6 descendants of its own
- K181166: Trilogy Evo (2019), 5 descendants of its own
- K193586: Vivo 45 LS (2021), 2 descendants of its own
- K102465: Bipap Avaps Ventilatory Support System (2011), 1 descendant of its own

## Recalls of this device
- 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 Respironics BiPAP AVAPS Ventilatory System is intended to provide non-invasive ventilatory support to treat adult and pediatric (> 7 years of age; > 40 Ibs) patients with obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP AVAPS Ventilatory System may be used in the hospital or home.

Source page: https://510kreport.com/device/K092818
Methodology: https://510kreport.com/methodology