BreathePal Bilevel (GFM50-MD2201)— 510(k) K252078
Substantially EquivalentCompal Electronics, Inc.
FDA 510(k) clearance K252078 for BreathePal Bilevel (GFM50-MD2201), Substantially Equivalent on 2026-03-17. Applicant: Compal Electronics, Inc.. Device class: 2.
Summary
Compal Electronics' BreathePal Bilevel (GFM50-MD2201) is filed under MNS, continuous non-life-supporting ventilators. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 868.5895. It was a Traditional 510(k), and Anesthesiology is both the classification panel and the review panel.
Compal Electronics filed from Taipei City, Taiwan. The decision came 258 calendar days after FDA received it (July 2, 2025 to March 17, 2026).
Clearance details
- Applicant
- Compal Electronics, Inc.
- Product code
- Product code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei City, TW
Recent devices under product code MNS
view allMore clearances from Compal Electronics, Inc.
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.