# K252078: BreathePal Bilevel  (GFM50-MD2201)

- Pathway: 510(k) (Traditional)
- Applicant: Compal Electronics, Inc.
- Decided: Mar 17, 2026 after 258 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: 11 generations back to K953930 (1996). 112 ancestors in all.
No later device cites it as a predicate yet.
7 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113053: Bipap a 30 Ventilatory Support System, Respironics, Inc. (2012) Summary page 5.

## Indications for use
The BreathePal Bilevel is intended to provide non-invasive ventilator (NIV) support for adult patients weighing over 30 kg (66lbs) who suffer from Obstructive Sleep Apnea (OSA) and Respiratory Impairment. It is intended for use in both home and clinical environment, including hospitals, sleep laboratories, and sub-acute care institutions.

Source page: https://510kreport.com/device/K252078
Methodology: https://510kreport.com/methodology