# K031656: Bipap Harmony Ventilatory Support System

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Jul 30, 2003 after 63 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: 3 generations back to K962517 (1997). 5 ancestors in all.
52 later devices descend from it; 4 cite it directly.
14 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012323: Bipap Synchrony Ventilatory Support System, Respironics, Inc. (2001)
- K011714: Bipap Pro BI-Level System, Respironics, Inc. (2001)

## Most influential descendants
- 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
- K050759: Bipap Auto (2005), 37 descendants of its own
- K063830: Remstar Aflex Cpap System (2007), 35 descendants of its own
- K063533: Bipap Synchrony (2007), 30 descendants of its own

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

Source page: https://510kreport.com/device/K031656
Methodology: https://510kreport.com/methodology