BreathePal Bilevel (GFM50-MD2201)— 510(k) K252078

Substantially Equivalent

Compal Electronics, Inc.

FDA 510(k) clearance K252078 for BreathePal Bilevel (GFM50-MD2201), Substantially Equivalent on 2026-03-17. Applicant: Compal Electronics, Inc..

Clearance details

Applicant: Compal Electronics, Inc.
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2025-07-02
Decision date: 2026-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.