# K070328: Bipap Synchrony with Avaps

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: May 8, 2007 after 92 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: 3 generations back to K962517 (1997). 7 ancestors in all.
59 later devices descend from it; 4 cite it directly.
14 of 67 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.
- K020777: Bipap Synchrony Ventilatory Support System with BI-Flex, Respironics, Inc. (2002) Summary page 1.

## Most influential descendants
- K083526: Trilogy 100 Ventilator (2009), 26 descendants of its own
- K090113: Breas Vivo 40 System (2009), 23 descendants of its own
- K103167: Stellar 150 (2011), 20 descendants of its own
- K093416: Trilogy 200 Ventilator (2010), 19 descendants of its own
- K082660: V60 Ventilator, Model V8000 (2009), 14 descendants of its own

## Indications for use
The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home. The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics. For use in the home or hospital/institutional environment on adult patients.

Source page: https://510kreport.com/device/K070328
Methodology: https://510kreport.com/methodology