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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 / K252440

510(k) cleared

EasyTeleMed (2.0.2)

Ingeniars S.R.L. · Oct 2, 2025 · K252440

FDA cleared the EasyTeleMed (2.0.2) from Ingeniars S.R.L. on Oct 2, 2025 under K252440, a traditional 510(k). The device falls under product code DRG, Transmitters And Receivers, Physiological Signal, Radiofrequency, regulated at 21 CFR 870.2910 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 4, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ingeniars S.R.L. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252440?

K252440 is the FDA 510(k) for EasyTeleMed (2.0.2), submitted by Ingeniars S.R.L.. FDA's decision date was Oct 2, 2025, under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).

Who makes the EasyTeleMed (2.0.2)?

Ingeniars S.R.L., based in Pisa, is the applicant of record for K252440.

How long did the K252440 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Oct 2, 2025, 59 days later.

← All decisions in October 2025