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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 / K253188

510(k) cleared

CoaguChek XS Plus System

Roche Diagnostics · Oct 24, 2025 · K253188

FDA cleared the CoaguChek XS Plus System from Roche Diagnostics on Oct 24, 2025 under K253188, a special 510(k). The device falls under product code GJS, Test, Time, Prothrombin, regulated at 21 CFR 864.7750 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Sep 26, 2025. The decision came 28 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 K253188?

K253188 is the FDA 510(k) for CoaguChek XS Plus System, submitted by Roche Diagnostics. FDA's decision date was Oct 24, 2025, under product code GJS (Test, Time, Prothrombin).

Who makes the CoaguChek XS Plus System?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K253188.

How long did the K253188 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Oct 24, 2025, 28 days later.

← All decisions in October 2025