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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 / K251899

510(k) cleared

E Blator

New Deantronics Taiwan , Ltd. · Oct 1, 2025 · K251899

FDA cleared the E Blator from New Deantronics Taiwan , Ltd. on Oct 1, 2025 under K251899, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 20, 2025. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

New Deantronics Taiwan , Ltd. has one other decision in the tracker over the last 12 months: K251492 (Irrigation Tubing Bipolar Cord Set).

Questions & Answers

What did FDA clear under K251899?

K251899 is the FDA 510(k) for E Blator, submitted by New Deantronics Taiwan , Ltd.. FDA's decision date was Oct 1, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the E Blator?

New Deantronics Taiwan , Ltd., based in New Taipei City, is the applicant of record for K251899.

How long did the K251899 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Oct 1, 2025, 103 days later.

← All decisions in October 2025

Sources