# K092043: Bipap Synchrony 2

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Aug 5, 2009 after 30 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: 6 generations back to K962517 (1997). 20 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063533: Bipap Synchrony, Respironics, Inc. (2007) Summary page 1.
- K071509: Bipap Synchrony 2 Ventilatory Support System, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K072592: Performax Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.

## Most influential descendants
- K101130: Bipap Synchrony 2 with AF531 Full Face Mask (2010), 1 descendant of its own
- K150639: AF541 EE Full Face Mask (2015), 0 descendants of its own
- K120562: Performax Pediatric EE Total Face Mask (2012), 0 descendants of its own
- K103395: Performax Total Face Mask (2011), 0 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/K092043
Methodology: https://510kreport.com/methodology