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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 / July 2026 / K253840

510(k) cleared

STEDI Scan Device

Stroke DX · Jul 22, 2026 · K253840

FDA cleared the STEDI Scan Device from Stroke DX on Jul 22, 2026 under K253840, a traditional 510(k). The device falls under product code QAF, Impedance Plethysmograph, Cranial, regulated at 21 CFR 870.2770 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 1, 2025. The decision came 233 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 Stroke DX in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253840?

K253840 is the FDA 510(k) for STEDI Scan Device, submitted by Stroke DX. FDA's decision date was Jul 22, 2026, under product code QAF (Impedance Plethysmograph, Cranial).

Who makes the STEDI Scan Device?

Stroke DX, based in Culver City, CA, is the applicant of record for K253840.

How long did the K253840 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Jul 22, 2026, 233 days later.

← All decisions in July 2026