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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 / March 2026 / K260355

510(k) cleared

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

WEBEST Biotech,, LLC · Mar 9, 2026 · K260355

FDA cleared the Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup from WEBEST Biotech,, LLC on Mar 9, 2026 under K260355, a traditional 510(k). The device falls under product code NFT, Test, Amphetamine, Over The Counter, regulated at 21 CFR 862.3100 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Feb 3, 2026. The decision came 34 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for WEBEST Biotech,, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260355?

K260355 is the FDA 510(k) for Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup, submitted by WEBEST Biotech,, LLC. FDA's decision date was Mar 9, 2026, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup?

WEBEST Biotech,, LLC, based in Irwindale, CA, is the applicant of record for K260355.

How long did the K260355 review take?

FDA received the submission on Feb 3, 2026 and issued its decision on Mar 9, 2026, 34 days later.

← All decisions in March 2026