# K012323: Bipap Synchrony Ventilatory Support System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Dec 20, 2001 after 150 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: 2 generations back to K962517 (1997). 2 ancestors in all.
91 later devices descend from it; 5 cite it directly.
24 of 94 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.

## Most influential descendants
- K070328: Bipap Synchrony with Avaps (2007), 59 descendants of its own
- K031656: Bipap Harmony Ventilatory Support System (2003), 52 descendants of its own
- K032834: Bipap Pro 2 BI-Level System (2004), 40 descendants of its own
- K043607: Bipap Pro 2 BI-Level System with BI-Flex (2005), 39 descendants of its own
- K050759: Bipap Auto (2005), 37 descendants of its own

## 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/K012323
Methodology: https://510kreport.com/methodology