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THE TAPE

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 / October 2025 / K250662

510(k) cleared

Bunkerhill MAC

BunkerHill Health · Oct 3, 2025 · K250662 · In the directory

FDA cleared the Bunkerhill MAC from BunkerHill Health on Oct 3, 2025 under K250662, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 5, 2025. The decision came 212 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), K250649 (Bunkerhill ECG-EF).

Questions & Answers

What did FDA clear under K250662?

K250662 is the FDA 510(k) for Bunkerhill MAC, submitted by BunkerHill Health. FDA's decision date was Oct 3, 2025, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Bunkerhill MAC?

BunkerHill Health, based in San Francisco, CA, is the applicant of record for K250662. The company is listed in the MedDevice Startups directory.

How long did the K250662 review take?

FDA received the submission on Mar 5, 2025 and issued its decision on Oct 3, 2025, 212 days later.

← All decisions in October 2025

Sources

In the startup directory

Bunkerhill Health

Imaging & Radiology · San Francisco, CA