# K101130: Bipap Synchrony 2 with AF531 Full Face Mask

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Sep 2, 2010 after 133 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: 7 generations back to K962517 (1997). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092043: Bipap Synchrony 2, Respironics, Inc. (2009) Summary page 1.
- K072592: Performax Total Face Mask, Respironics Inc., Sleep & Home Respiratory Group (2007) Summary page 1.
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.

## Most influential descendants
- K150639: AF541 EE Full Face Mask (2015), 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/K101130
Methodology: https://510kreport.com/methodology