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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 / July 2026 / K261984

510(k) cleared

AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup

Assure Tech., LLC · Jul 17, 2026 · K261984

FDA cleared the AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup from Assure Tech., LLC on Jul 17, 2026 under K261984, 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 Jun 12, 2026. The decision came 35 days later, inside the 90 FDA-day goal for a 510(k).

Assure Tech., LLC has one other decision in the tracker over the last 12 months: K260754 (Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test).

Questions & Answers

What did FDA clear under K261984?

K261984 is the FDA 510(k) for AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup, submitted by Assure Tech., LLC. FDA's decision date was Jul 17, 2026, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup?

Assure Tech., LLC, based in Wilmington, DE, is the applicant of record for K261984.

How long did the K261984 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Jul 17, 2026, 35 days later.

← All decisions in July 2026

Sources