WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / January 2026 / K250741

510(k) cleared

Evidence MultiSTAT DOA Urine MultiPlex

Randox Laboratories Limited · Jan 23, 2026 · K250741

FDA cleared the Evidence MultiSTAT DOA Urine MultiPlex from Randox Laboratories Limited on Jan 23, 2026 under K250741, a traditional 510(k). The device falls under product code DJG, Enzyme Immunoassay, Opiates, regulated at 21 CFR 862.3650 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Mar 11, 2025. The decision came 318 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 Randox Laboratories Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250741?

K250741 is the FDA 510(k) for Evidence MultiSTAT DOA Urine MultiPlex, submitted by Randox Laboratories Limited. FDA's decision date was Jan 23, 2026, under product code DJG (Enzyme Immunoassay, Opiates).

Who makes the Evidence MultiSTAT DOA Urine MultiPlex?

Randox Laboratories Limited, based in Crumlin, is the applicant of record for K250741.

How long did the K250741 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Jan 23, 2026, 318 days later.

← All decisions in January 2026