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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 / June 2026 / K252323

510(k) cleared

cobas pulse blood glucose monitoring system

Roche Diagnostics · Jun 12, 2026 · K252323

FDA cleared the cobas pulse blood glucose monitoring system from Roche Diagnostics on Jun 12, 2026 under K252323, a dual track 510(k). The device falls under product code PZI, Prescription Use Blood Glucose Meter For Near-Patient Testing, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 25, 2025. The decision came 322 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 K252323?

K252323 is the FDA 510(k) for cobas pulse blood glucose monitoring system, submitted by Roche Diagnostics. FDA's decision date was Jun 12, 2026, under product code PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing).

Who makes the cobas pulse blood glucose monitoring system?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K252323.

How long did the K252323 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Jun 12, 2026, 322 days later.

← All decisions in June 2026