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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 / September 2025 / K250649

510(k) cleared

Bunkerhill ECG-EF

BunkerHill Health · Sep 19, 2025 · K250649 · In the directory

FDA cleared the Bunkerhill ECG-EF from BunkerHill Health on Sep 19, 2025 under K250649, a traditional 510(k). The device falls under product code QYE, Reduced Ejection Fraction Machine Learning-Based Notification Software, regulated at 21 CFR 870.2380 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 4, 2025. The decision came 199 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BunkerHill Health has 3 other decisions in the tracker over the last 12 months: K260166 (Bunkerhill Contrast CAC), K260167 (Bunkerhill Contrast AVC), K250662 (Bunkerhill MAC).

Questions & Answers

What did FDA clear under K250649?

K250649 is the FDA 510(k) for Bunkerhill ECG-EF, submitted by BunkerHill Health. FDA's decision date was Sep 19, 2025, under product code QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software).

Who makes the Bunkerhill ECG-EF?

BunkerHill Health, based in San Francisco, CA, is the applicant of record for K250649. The company is listed in the MedDevice Startups directory.

How long did the K250649 review take?

FDA received the submission on Mar 4, 2025 and issued its decision on Sep 19, 2025, 199 days later.

← All decisions in September 2025

Sources

In the startup directory

Bunkerhill Health

Imaging & Radiology · San Francisco, CA