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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 / December 2025 / K253293

510(k) cleared

VitaloJAK Clinic (Model 7100)

Vitalograph , Ltd. · Dec 3, 2025 · K253293

FDA cleared the VitaloJAK Clinic (Model 7100) from Vitalograph , Ltd. on Dec 3, 2025 under K253293, a special 510(k). The device falls under product code DSH, Recorder, Magnetic Tape, Medical, regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 29, 2025. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Vitalograph , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253293?

K253293 is the FDA 510(k) for VitaloJAK Clinic (Model 7100), submitted by Vitalograph , Ltd.. FDA's decision date was Dec 3, 2025, under product code DSH (Recorder, Magnetic Tape, Medical).

Who makes the VitaloJAK Clinic (Model 7100)?

Vitalograph , Ltd., based in Ennis Co. Clare, is the applicant of record for K253293.

How long did the K253293 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 3, 2025, 65 days later.

← All decisions in December 2025