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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 / November 2025 / K252550

510(k) cleared

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

Guangzhou Wondfo Biotech Co., Ltd. · Nov 18, 2025 · K252550

FDA cleared the SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx from Guangzhou Wondfo Biotech Co., Ltd. on Nov 18, 2025 under K252550, 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 Aug 13, 2025. The decision came 97 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: K260065 (SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx), K251289 (WELLlife COVID-19 Antigen Test Rx).

Questions & Answers

What did FDA clear under K252550?

K252550 is the FDA 510(k) for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx, submitted by Guangzhou Wondfo Biotech Co., Ltd.. FDA's decision date was Nov 18, 2025, under product code NFT (Test, Amphetamine, Over The Counter).

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

Guangzhou Wondfo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K252550.

How long did the K252550 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on Nov 18, 2025, 97 days later.

← All decisions in November 2025

Sources