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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 / July 2026 / K262116

510(k) cleared

TRUE METRIX Self Monitoring Blood Glucose System

Trividia Health, Inc. · Jul 23, 2026 · K262116

FDA cleared the TRUE METRIX Self Monitoring Blood Glucose System from Trividia Health, Inc. on Jul 23, 2026 under K262116, a special 510(k). The device falls under product code NBW, System, Test, Blood Glucose, Over The Counter, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 23, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Trividia Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262116?

K262116 is the FDA 510(k) for TRUE METRIX Self Monitoring Blood Glucose System, submitted by Trividia Health, Inc.. FDA's decision date was Jul 23, 2026, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the TRUE METRIX Self Monitoring Blood Glucose System?

Trividia Health, Inc., based in Fort Lauderdale, FL, is the applicant of record for K262116.

How long did the K262116 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Jul 23, 2026, 30 days later.

← All decisions in July 2026