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The Tracker / October 2026 / K261293

510(k) cleared

EASYMAX Voice Blood Glucose Monitoring System

EPS Bio Technology Corp. · Oct 23, 2026 · K261293

FDA cleared the EASYMAX Voice Blood Glucose Monitoring System from EPS Bio Technology Corp. on Oct 23, 2026 under K261293, 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 Apr 20, 2026. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for EPS Bio Technology Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261293?

K261293 is the FDA 510(k) for EASYMAX Voice Blood Glucose Monitoring System, submitted by EPS Bio Technology Corp.. FDA's decision date was Oct 23, 2026, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the EASYMAX Voice Blood Glucose Monitoring System?

EPS Bio Technology Corp., based in Hsinchu, is the applicant of record for K261293.

How long did the K261293 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Oct 23, 2026, 186 days later.

← All decisions in October 2026