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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 / February 2026 / DEN250007

510(k) cleared

Delivery Date AI

Ultrasound AI · Feb 11, 2026 · DEN250007

FDA cleared the Delivery Date AI from Ultrasound AI on Feb 11, 2026 under DEN250007, a direct 510(k). The device falls under product code SHE, Radiological Software System For Delivery Date Prediction, regulated at 21 CFR 892.8200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 17, 2025. The decision came 331 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 Ultrasound AI in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250007?

DEN250007 is the FDA 510(k) for Delivery Date AI, submitted by Ultrasound AI. FDA's decision date was Feb 11, 2026, under product code SHE (Radiological Software System For Delivery Date Prediction).

Who makes the Delivery Date AI?

Ultrasound AI, based in Greenwood Village, CO, is the applicant of record for DEN250007.

How long did the DEN250007 review take?

FDA received the submission on Mar 17, 2025 and issued its decision on Feb 11, 2026, 331 days later.

← All decisions in February 2026