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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 / April 2026 / K253473

510(k) cleared

Synchrony

Stereotaxis, Inc. · Apr 1, 2026 · K253473

FDA cleared the Synchrony from Stereotaxis, Inc. on Apr 1, 2026 under K253473, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 10, 2025. The decision came 173 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stereotaxis, Inc. has 2 other decisions in the tracker over the last 12 months: P240014 (MAGiC Ablation Catheter), K251792 (Stereotaxis GenesisX RMN with Navigant Workstation (NWS)).

Questions & Answers

What did FDA clear under K253473?

K253473 is the FDA 510(k) for Synchrony, submitted by Stereotaxis, Inc.. FDA's decision date was Apr 1, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the Synchrony?

Stereotaxis, Inc., based in Saint Louis, MO, is the applicant of record for K253473.

How long did the K253473 review take?

FDA received the submission on Oct 10, 2025 and issued its decision on Apr 1, 2026, 173 days later.

← All decisions in April 2026

Sources