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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 / K253861

510(k) cleared

ACORYS MAPPING SYSTEM

Corify Care S.L · Apr 13, 2026 · K253861

FDA cleared the ACORYS MAPPING SYSTEM from Corify Care S.L on Apr 13, 2026 under K253861, 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 Dec 3, 2025. The decision came 131 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 Corify Care S.L in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253861?

K253861 is the FDA 510(k) for ACORYS MAPPING SYSTEM, submitted by Corify Care S.L. FDA's decision date was Apr 13, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the ACORYS MAPPING SYSTEM?

Corify Care S.L, based in Madrid, is the applicant of record for K253861.

How long did the K253861 review take?

FDA received the submission on Dec 3, 2025 and issued its decision on Apr 13, 2026, 131 days later.

← All decisions in April 2026