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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 / October 2025 / K253242

510(k) cleared

LCD Monitor (C1216W, C822W, C821W)

Shenzhen Beacon Display Technology Co., Ltd. · Oct 29, 2025 · K253242

FDA cleared the LCD Monitor (C1216W, C822W, C821W) from Shenzhen Beacon Display Technology Co., Ltd. on Oct 29, 2025 under K253242, a special 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 Sep 29, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Beacon Display Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252780 (LCD Monitor (CL1902A, CL2103F)).

Questions & Answers

What did FDA clear under K253242?

K253242 is the FDA 510(k) for LCD Monitor (C1216W, C822W, C821W), submitted by Shenzhen Beacon Display Technology Co., Ltd.. FDA's decision date was Oct 29, 2025, under product code PGY (Display, Diagnostic Radiology).

Who makes the LCD Monitor (C1216W, C822W, C821W)?

Shenzhen Beacon Display Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253242.

How long did the K253242 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Oct 29, 2025, 30 days later.

← All decisions in October 2025

Sources