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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 / June 2026 / K260614

510(k) cleared

Tinnitus Therapy

Sivantos GmbH · Jun 10, 2026 · K260614

FDA cleared the Tinnitus Therapy from Sivantos GmbH on Jun 10, 2026 under K260614, a special 510(k). The device falls under product code KLW, Masker, Tinnitus, regulated at 21 CFR 874.3400 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 25, 2026. The decision came 105 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 Sivantos GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260614?

K260614 is the FDA 510(k) for Tinnitus Therapy, submitted by Sivantos GmbH. FDA's decision date was Jun 10, 2026, under product code KLW (Masker, Tinnitus).

Who makes the Tinnitus Therapy?

Sivantos GmbH, based in Erlangen, is the applicant of record for K260614.

How long did the K260614 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on Jun 10, 2026, 105 days later.

← All decisions in June 2026