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 / July 2026 / K252463

510(k) cleared

SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)

Edan Instruments, Inc. · Jul 2, 2026 · K252463

FDA cleared the SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) from Edan Instruments, Inc. on Jul 2, 2026 under K252463, a traditional 510(k). The device falls under product code DPS, Electrocardiograph, regulated at 21 CFR 870.2340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 6, 2025. The decision came 330 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Edan Instruments, Inc. has 3 other decisions in the tracker over the last 12 months: K251508 (Telemetry Monitor (iT30, iT50)), K251591 (Holter ECG and ABP system (HolterABP)), K251268 (Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)).

Questions & Answers

What did FDA clear under K252463?

K252463 is the FDA 510(k) for SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E), submitted by Edan Instruments, Inc.. FDA's decision date was Jul 2, 2026, under product code DPS (Electrocardiograph).

Who makes the SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)?

Edan Instruments, Inc., based in Shenzhen, is the applicant of record for K252463.

How long did the K252463 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Jul 2, 2026, 330 days later.

← All decisions in July 2026

Sources