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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 / May 2026 / K254115

510(k) cleared

ArteraAI Breast

Artera, Inc. · May 4, 2026 · K254115

FDA cleared the ArteraAI Breast from Artera, Inc. on May 4, 2026 under K254115, a traditional 510(k). The device falls under product code SHW, Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis, regulated at 21 CFR 864.3755 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Dec 19, 2025. The decision came 136 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 Artera, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254115?

K254115 is the FDA 510(k) for ArteraAI Breast, submitted by Artera, Inc.. FDA's decision date was May 4, 2026, under product code SHW (Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis).

Who makes the ArteraAI Breast?

Artera, Inc., based in Los Altos, CA, is the applicant of record for K254115.

How long did the K254115 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 4, 2026, 136 days later.

← All decisions in May 2026