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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 / October 2025 / K250073

510(k) cleared

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

Tosoh Bioscience, Inc. · Oct 3, 2025 · K250073

FDA cleared the Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 from Tosoh Bioscience, Inc. on Oct 3, 2025 under K250073, a traditional 510(k). The device falls under product code PDJ, Hemoglobin A1c Test System, regulated at 21 CFR 862.1373 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jan 10, 2025. The decision came 266 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 Tosoh Bioscience, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250073?

K250073 is the FDA 510(k) for Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01, submitted by Tosoh Bioscience, Inc.. FDA's decision date was Oct 3, 2025, under product code PDJ (Hemoglobin A1c Test System).

Who makes the Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01?

Tosoh Bioscience, Inc., based in Grove City, OH, is the applicant of record for K250073.

How long did the K250073 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Oct 3, 2025, 266 days later.

← All decisions in October 2025