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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 / January 2026 / K253318

510(k) cleared

Clungene RSV Antigen Rapid Test

Hangzhou Clongene Biotech Co., Ltd. · Jan 30, 2026 · K253318

FDA cleared the Clungene RSV Antigen Rapid Test from Hangzhou Clongene Biotech Co., Ltd. on Jan 30, 2026 under K253318, a traditional 510(k). The device falls under product code GQG, Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, regulated at 21 CFR 866.3480 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 30, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hangzhou Clongene Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253318?

K253318 is the FDA 510(k) for Clungene RSV Antigen Rapid Test, submitted by Hangzhou Clongene Biotech Co., Ltd.. FDA's decision date was Jan 30, 2026, under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus).

Who makes the Clungene RSV Antigen Rapid Test?

Hangzhou Clongene Biotech Co., Ltd., based in Hangzhou, is the applicant of record for K253318.

How long did the K253318 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 30, 2026, 122 days later.

← All decisions in January 2026