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 / October 2025 / K251289

510(k) cleared

WELLlife COVID-19 Antigen Test Rx

Guangzhou Wondfo Biotech Co., Ltd. · Oct 22, 2025 · K251289

FDA cleared the WELLlife COVID-19 Antigen Test Rx from Guangzhou Wondfo Biotech Co., Ltd. on Oct 22, 2025 under K251289, a dual track 510(k). The device falls under product code QVF, Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, regulated at 21 CFR 866.3982 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Apr 25, 2025. The decision came 180 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), K252550 (SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx).

Questions & Answers

What did FDA clear under K251289?

K251289 is the FDA 510(k) for WELLlife COVID-19 Antigen Test Rx, submitted by Guangzhou Wondfo Biotech Co., Ltd.. FDA's decision date was Oct 22, 2025, under product code QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings).

Who makes the WELLlife COVID-19 Antigen Test Rx?

Guangzhou Wondfo Biotech Co., Ltd., based in Guangzhou, is the applicant of record for K251289.

How long did the K251289 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Oct 22, 2025, 180 days later.

← All decisions in October 2025

Sources