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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 / September 2025 / K251040

510(k) cleared

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

Guangzhou Decheng Biotechnology Co., Ltd. · Sep 9, 2025 · K251040

FDA cleared the MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test from Guangzhou Decheng Biotechnology Co., Ltd. on Sep 9, 2025 under K251040, a traditional 510(k). The device falls under product code LCX, Kit, Test, Pregnancy, Hcg, Over The Counter, regulated at 21 CFR 862.1155 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 3, 2025. The decision came 159 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 Guangzhou Decheng Biotechnology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251040?

K251040 is the FDA 510(k) for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test, submitted by Guangzhou Decheng Biotechnology Co., Ltd.. FDA's decision date was Sep 9, 2025, under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter).

Who makes the MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

Guangzhou Decheng Biotechnology Co., Ltd., based in Guangzhou, is the applicant of record for K251040.

How long did the K251040 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Sep 9, 2025, 159 days later.

← All decisions in September 2025