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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 / February 2026 / K251591

510(k) cleared

Holter ECG and ABP system (HolterABP)

Edan Instruments, Inc. · Feb 9, 2026 · K251591

FDA cleared the Holter ECG and ABP system (HolterABP) from Edan Instruments, Inc. on Feb 9, 2026 under K251591, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 23, 2025. The decision came 262 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)), K252463 (SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)), K251268 (Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)).

Questions & Answers

What did FDA clear under K251591?

K251591 is the FDA 510(k) for Holter ECG and ABP system (HolterABP), submitted by Edan Instruments, Inc.. FDA's decision date was Feb 9, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the Holter ECG and ABP system (HolterABP)?

Edan Instruments, Inc., based in Shenzhen, is the applicant of record for K251591.

How long did the K251591 review take?

FDA received the submission on May 23, 2025 and issued its decision on Feb 9, 2026, 262 days later.

← All decisions in February 2026

Sources