# K020777: Bipap Synchrony Ventilatory Support System with BI-Flex

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Mar 20, 2002 after 9 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000994 (2000). 3 ancestors in all.
61 later devices descend from it; 2 cite it directly.
15 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010263: Remstar Plus Cpap System, Respironics, Inc. (2001) Summary page 1.
- K011714: Bipap Pro BI-Level System, Respironics, Inc. (2001) Summary page 1.

## Most influential descendants
- K070328: Bipap Synchrony with Avaps (2007), 59 descendants of its own
- 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

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1061-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1088-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The Synchrony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. 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.

Source page: https://510kreport.com/device/K020777
Methodology: https://510kreport.com/methodology