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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 / K252163

510(k) cleared

Elecsys Phospho-Tau (181P) Plasma

Roche Diagnostics · Oct 8, 2025 · K252163

FDA cleared the Elecsys Phospho-Tau (181P) Plasma from Roche Diagnostics on Oct 8, 2025 under K252163, a traditional 510(k). The device falls under product code SET, Immunoassay Blood Test For Amyloid Pathology Assessment, regulated at 21 CFR 866.5840 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Jul 10, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Roche Diagnostics has 8 other decisions in the tracker over the last 12 months: K252323 (cobas pulse blood glucose monitoring system), K252431 (Elecsys Calcitonin), K252280 (Elecsys Anti-SARS-CoV-2 S), K260046 (Elecsys Anti-HBc II).

Questions & Answers

What did FDA clear under K252163?

K252163 is the FDA 510(k) for Elecsys Phospho-Tau (181P) Plasma, submitted by Roche Diagnostics. FDA's decision date was Oct 8, 2025, under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment).

Who makes the Elecsys Phospho-Tau (181P) Plasma?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K252163.

How long did the K252163 review take?

FDA received the submission on Jul 10, 2025 and issued its decision on Oct 8, 2025, 90 days later.

← All decisions in October 2025