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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 / June 2026 / K261213

510(k) cleared

Medical Monitor (40HT513D)

Lg Electronics.Inc · Jun 12, 2026 · K261213

FDA cleared the Medical Monitor (40HT513D) from Lg Electronics.Inc on Jun 12, 2026 under K261213, a traditional 510(k). The device falls under product code PGY, Display, Diagnostic Radiology, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 14, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Lg Electronics.Inc has one other decision in the tracker over the last 12 months: K261614 (LED LCD Monitor (OEV-271H)).

Questions & Answers

What did FDA clear under K261213?

K261213 is the FDA 510(k) for Medical Monitor (40HT513D), submitted by Lg Electronics.Inc. FDA's decision date was Jun 12, 2026, under product code PGY (Display, Diagnostic Radiology).

Who makes the Medical Monitor (40HT513D)?

Lg Electronics.Inc, based in Gumi-Si, is the applicant of record for K261213.

How long did the K261213 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on Jun 12, 2026, 59 days later.

← All decisions in June 2026

Sources