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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 / February 2026 / K253490

510(k) cleared

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

Roche Diagnostics · Feb 12, 2026 · K253490

FDA cleared the Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions from Roche Diagnostics on Feb 12, 2026 under K253490, a traditional 510(k). The device falls under product code CFR, Hexokinase, Glucose, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Oct 24, 2025. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K253490?

K253490 is the FDA 510(k) for Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions, submitted by Roche Diagnostics. FDA's decision date was Feb 12, 2026, under product code CFR (Hexokinase, Glucose).

Who makes the Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K253490.

How long did the K253490 review take?

FDA received the submission on Oct 24, 2025 and issued its decision on Feb 12, 2026, 111 days later.

← All decisions in February 2026