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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252078

510(k) cleared

BreathePal Bilevel (GFM50-MD2201)

Compal Electronics, Inc. · Mar 17, 2026 · K252078

FDA cleared the BreathePal Bilevel (GFM50-MD2201) from Compal Electronics, Inc. on Mar 17, 2026 under K252078, a traditional 510(k). The device falls under product code MNS, Ventilator, Continuous, Non-Life-Supporting, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jul 2, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Compal Electronics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252078?

K252078 is the FDA 510(k) for BreathePal Bilevel (GFM50-MD2201), submitted by Compal Electronics, Inc.. FDA's decision date was Mar 17, 2026, under product code MNS (Ventilator, Continuous, Non-Life-Supporting).

Who makes the BreathePal Bilevel (GFM50-MD2201)?

Compal Electronics, Inc., based in Taipei City, is the applicant of record for K252078.

How long did the K252078 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Mar 17, 2026, 258 days later.

← All decisions in March 2026