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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 / K253586

510(k) cleared

RM Electrode (RMH 25-01)

Retmap, Inc. · Apr 1, 2026 · K253586

FDA cleared the RM Electrode (RMH 25-01) from Retmap, Inc. on Apr 1, 2026 under K253586, a traditional 510(k). The device falls under product code HLZ, Electrode, Corneal, regulated at 21 CFR 886.1220 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Nov 17, 2025. The decision came 135 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 Retmap, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253586?

K253586 is the FDA 510(k) for RM Electrode (RMH 25-01), submitted by Retmap, Inc.. FDA's decision date was Apr 1, 2026, under product code HLZ (Electrode, Corneal).

Who makes the RM Electrode (RMH 25-01)?

Retmap, Inc., based in Chicago, IL, is the applicant of record for K253586.

How long did the K253586 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Apr 1, 2026, 135 days later.

← All decisions in April 2026