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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K260221 (Elecsys EBV EBNA IgG), K260232 (Elecsys EBV VCA IgG), K260233 (Elecsys EBV IgM), K261686 (Elecsys Phospho-Tau (217P) Plasma).

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