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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 one other decision in the tracker over the last 12 months: K260167 (Bunkerhill Contrast AVC).

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