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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 / March 2026 / K253205

510(k) cleared

OptiMap Catheter - 50mm (OPTI-CATH2-50)

Cortex, Inc. · Mar 13, 2026 · K253205

FDA cleared the OptiMap Catheter - 50mm (OPTI-CATH2-50) from Cortex, Inc. on Mar 13, 2026 under K253205, a traditional 510(k). The device falls under product code MTD, Catheter, Intracardiac Mapping, High-Density Array, regulated at 21 CFR 870.1220 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 26, 2025. The decision came 168 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Cortex, Inc. has one other decision in the tracker over the last 12 months: K261012 (OptiMap Catheter - 60mm (OPTI-CATH2-60)).

Questions & Answers

What did FDA clear under K253205?

K253205 is the FDA 510(k) for OptiMap Catheter - 50mm (OPTI-CATH2-50), submitted by Cortex, Inc.. FDA's decision date was Mar 13, 2026, under product code MTD (Catheter, Intracardiac Mapping, High-Density Array).

Who makes the OptiMap Catheter - 50mm (OPTI-CATH2-50)?

Cortex, Inc., based in Santa Clara, CA, is the applicant of record for K253205.

How long did the K253205 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Mar 13, 2026, 168 days later.

← All decisions in March 2026

Sources