K252078 is an FDA 510(k) clearance for the BreathePal Bilevel (GFM50-MD2201). This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Compal Electronics, Inc. (Taipei City, TW). The FDA issued a Cleared decision on March 17, 2026, 258 days after receiving the submission on July 2, 2025.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K252078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2025 |
| Decision Date | March 17, 2026 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNS — Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |