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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 / December 2025 / K252981

510(k) cleared

EmbraceMini

Empatica S.r.l. · Dec 22, 2025 · K252981

FDA cleared the EmbraceMini from Empatica S.r.l. on Dec 22, 2025 under K252981, a traditional 510(k). The device falls under product code LEL, Device, Sleep Assessment, regulated at 21 CFR 882.5050 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 17, 2025. The decision came 96 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Empatica S.r.l. has one other decision in the tracker over the last 12 months: K260374 (Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal).

Questions & Answers

What did FDA clear under K252981?

K252981 is the FDA 510(k) for EmbraceMini, submitted by Empatica S.r.l.. FDA's decision date was Dec 22, 2025, under product code LEL (Device, Sleep Assessment).

Who makes the EmbraceMini?

Empatica S.r.l., based in Milan, is the applicant of record for K252981.

How long did the K252981 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Dec 22, 2025, 96 days later.

← All decisions in December 2025

Sources