# K992530: Bipap Synchrony HC

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Mar 20, 2000 after 236 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: 1 generation back to K962517 (1997). 1 ancestor in all.
92 later devices descend from it; 4 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)
- K962517: Model 7700 Quantum Pressure Support Ventilator PSV, Healthdyne Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K012323: Bipap Synchrony Ventilatory Support System (2001), 91 descendants of its own
- 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

## Indications for use
The BiPAP Synchrony is intended to provide non-invasive ventilation in adult patients (>30kg) for the treatment of respiratory insufficdency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The Synchrony ventilator is intended for use with nasal masks and full-face masks as recommended by Respironics.

Source page: https://510kreport.com/device/K992530
Methodology: https://510kreport.com/methodology