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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 / 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: K252431 (Elecsys Calcitonin), K252280 (Elecsys Anti-SARS-CoV-2 S), K260046 (Elecsys Anti-HBc II), K260048 (Elecsys Anti-HAV IgM).

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