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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 / January 2026 / K252767

510(k) cleared

actiTENS mini

Sublimed · Jan 16, 2026 · K252767

FDA cleared the actiTENS mini from Sublimed on Jan 16, 2026 under K252767, a traditional 510(k). The device falls under product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 29, 2025. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sublimed in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252767?

K252767 is the FDA 510(k) for actiTENS mini, submitted by Sublimed. FDA's decision date was Jan 16, 2026, under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief).

Who makes the actiTENS mini?

Sublimed, based in Moirans, is the applicant of record for K252767.

How long did the K252767 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Jan 16, 2026, 140 days later.

← All decisions in January 2026