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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 / August 2026 / K251508

510(k) cleared

Telemetry Monitor (iT30, iT50)

Edan Instruments, Inc. · Aug 6, 2026 · K251508

FDA cleared the Telemetry Monitor (iT30, iT50) from Edan Instruments, Inc. on Aug 6, 2026 under K251508, a traditional 510(k). The device falls under product code MHX, Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.1025 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 16, 2025. The decision came 447 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: K252463 (SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)), 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 K251508?

K251508 is the FDA 510(k) for Telemetry Monitor (iT30, iT50), submitted by Edan Instruments, Inc.. FDA's decision date was Aug 6, 2026, under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Who makes the Telemetry Monitor (iT30, iT50)?

Edan Instruments, Inc., based in Shenzhen, is the applicant of record for K251508.

How long did the K251508 review take?

FDA received the submission on May 16, 2025 and issued its decision on Aug 6, 2026, 447 days later.

← All decisions in August 2026

Sources