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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 / K253055

510(k) cleared

Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)

Nordic Kinetics AB · Jun 17, 2026 · K253055

FDA cleared the Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW) from Nordic Kinetics AB on Jun 17, 2026 under K253055, a traditional 510(k). The device falls under product code GYD, Transducer, Tremor, regulated at 21 CFR 882.1950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 22, 2025. The decision came 268 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 Nordic Kinetics AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253055?

K253055 is the FDA 510(k) for Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW), submitted by Nordic Kinetics AB. FDA's decision date was Jun 17, 2026, under product code GYD (Transducer, Tremor).

Who makes the Sine Monitoring Parkinsons Disease Tremor Dyskinesia Apple Watch (SMPDTDAW)?

Nordic Kinetics AB, based in Lund, is the applicant of record for K253055.

How long did the K253055 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jun 17, 2026, 268 days later.

← All decisions in June 2026