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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 / K253141

510(k) cleared

DeepRhythmAI

Medicalgorithmics S.A. · Dec 11, 2025 · K253141

FDA cleared the DeepRhythmAI from Medicalgorithmics S.A. on Dec 11, 2025 under K253141, 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 Sep 25, 2025. The decision came 77 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medicalgorithmics S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253141?

K253141 is the FDA 510(k) for DeepRhythmAI, submitted by Medicalgorithmics S.A.. FDA's decision date was Dec 11, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the DeepRhythmAI?

Medicalgorithmics S.A., based in Warsaw, is the applicant of record for K253141.

How long did the K253141 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Dec 11, 2025, 77 days later.

← All decisions in December 2025