# K063533: Bipap Synchrony

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Feb 20, 2007 after 90 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: 4 generations back to K962517 (1997). 11 ancestors in all.
30 later devices descend from it; 4 cite it directly.
8 of 42 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.
- K031656: Bipap Harmony Ventilatory Support System, Respironics, Inc. (2003) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.

## Most influential descendants
- K071509: Bipap Synchrony 2 Ventilatory Support System (2007), 28 descendants of its own
- K092818: Bipap Avaps Ventilatory Support System (2010), 11 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- 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

## Indications for use
The Respironics BiPAP Synchrony 2 is intended to provide non-invasive ventilation for pediatric patients 7 years or older (> 40 lbs) and adult patients (> 66 lbs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

Source page: https://510kreport.com/device/K063533
Methodology: https://510kreport.com/methodology