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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 / K253733

510(k) cleared

STAR Apollo Mapping System

Rhythm AI, Ltd. · Dec 19, 2025 · K253733

FDA cleared the STAR Apollo Mapping System from Rhythm AI, Ltd. on Dec 19, 2025 under K253733, a special 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 Nov 24, 2025. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253733?

K253733 is the FDA 510(k) for STAR Apollo Mapping System, submitted by Rhythm AI, Ltd.. FDA's decision date was Dec 19, 2025, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the STAR Apollo Mapping System?

Rhythm AI, Ltd., based in London, is the applicant of record for K253733.

How long did the K253733 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 19, 2025, 25 days later.

← All decisions in December 2025