WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K252780

510(k) cleared

LCD Monitor (CL1902A, CL2103F)

Shenzhen Beacon Display Technology Co., Ltd. · Dec 19, 2025 · K252780

FDA cleared the LCD Monitor (CL1902A, CL2103F) from Shenzhen Beacon Display Technology Co., Ltd. on Dec 19, 2025 under K252780, 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 Sep 2, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Beacon Display Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253242 (LCD Monitor (C1216W, C822W, C821W)).

Questions & Answers

What did FDA clear under K252780?

K252780 is the FDA 510(k) for LCD Monitor (CL1902A, CL2103F), submitted by Shenzhen Beacon Display Technology Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code PGY (Display, Diagnostic Radiology).

Who makes the LCD Monitor (CL1902A, CL2103F)?

Shenzhen Beacon Display Technology Co., Ltd., based in Shenzhen, is the applicant of record for K252780.

How long did the K252780 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Dec 19, 2025, 108 days later.

← All decisions in December 2025

Sources