# K071509: Bipap Synchrony 2 Ventilatory Support System

- Pathway: 510(k) (Special)
- Applicant: Respironics Inc., Sleep & Home Respiratory Group
- Decided: Aug 8, 2007 after 65 days
- Product code: MNS (Ventilator, Continuous, Non-Life-Supporting)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962517 (1997). 16 ancestors in all.
28 later devices descend from it; 3 cite it directly.
7 of 45 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.
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K181166: Trilogy Evo (2019), 5 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1061-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1088-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## 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 Ibs) with respiratory insufficiency or obstructive sleep apnea, in the hospital or home.

Source page: https://510kreport.com/device/K071509
Methodology: https://510kreport.com/methodology