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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 / April 2026 / K260065

510(k) cleared

SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx

Guangzhou Wondfo Biotech Co., Ltd. · Apr 28, 2026 · K260065

FDA cleared the SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx from Guangzhou Wondfo Biotech Co., Ltd. on Apr 28, 2026 under K260065, 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 Jan 9, 2026. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guangzhou Wondfo Biotech Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252550 (SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx), K251289 (WELLlife COVID-19 Antigen Test Rx).

Questions & Answers

What did FDA clear under K260065?

K260065 is the FDA 510(k) for SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx, submitted by Guangzhou Wondfo Biotech Co., Ltd.. FDA's decision date was Apr 28, 2026, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx?

Guangzhou Wondfo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K260065.

How long did the K260065 review take?

FDA received the submission on Jan 9, 2026 and issued its decision on Apr 28, 2026, 109 days later.

← All decisions in April 2026

Sources