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THE TAPE

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 / February 2026 / K252619

510(k) cleared

QSCHECK UISACR

Qstag, Inc. · Feb 20, 2026 · K252619

FDA cleared the QSCHECK UISACR from Qstag, Inc. on Feb 20, 2026 under K252619, a traditional 510(k). The device falls under product code JFY, Enzymatic Method, Creatinine, regulated at 21 CFR 862.1225 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 19, 2025. The decision came 185 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 Qstag, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252619?

K252619 is the FDA 510(k) for QSCHECK UISACR, submitted by Qstag, Inc.. FDA's decision date was Feb 20, 2026, under product code JFY (Enzymatic Method, Creatinine).

Who makes the QSCHECK UISACR?

Qstag, Inc., based in Incheon, is the applicant of record for K252619.

How long did the K252619 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Feb 20, 2026, 185 days later.

← All decisions in February 2026