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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 / March 2026 / K260166

510(k) cleared

Bunkerhill Contrast CAC

BunkerHill Health · Mar 6, 2026 · K260166 · In the directory

FDA cleared the Bunkerhill Contrast CAC from BunkerHill Health on Mar 6, 2026 under K260166, 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 Jan 20, 2026. The decision came 45 days later, inside the 90 FDA-day goal for a 510(k).

BunkerHill Health has 3 other decisions in the tracker over the last 12 months: K260167 (Bunkerhill Contrast AVC), K250662 (Bunkerhill MAC), K250649 (Bunkerhill ECG-EF).

Questions & Answers

What did FDA clear under K260166?

K260166 is the FDA 510(k) for Bunkerhill Contrast CAC, submitted by BunkerHill Health. FDA's decision date was Mar 6, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the Bunkerhill Contrast CAC?

BunkerHill Health, based in San Francisco, CA, is the applicant of record for K260166. The company is listed in the MedDevice Startups directory.

How long did the K260166 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Mar 6, 2026, 45 days later.

← All decisions in March 2026

Sources

In the startup directory

Bunkerhill Health

Imaging & Radiology · San Francisco, CA