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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 / March 2026 / K253983

510(k) cleared

Water-based lubricant

Guangzhou Haoyimai Trading Co., Ltd. · Mar 6, 2026 · K253983

FDA cleared the Water-based lubricant from Guangzhou Haoyimai Trading Co., Ltd. on Mar 6, 2026 under K253983, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 12, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guangzhou Haoyimai Trading Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253983?

K253983 is the FDA 510(k) for Water-based lubricant, submitted by Guangzhou Haoyimai Trading Co., Ltd.. FDA's decision date was Mar 6, 2026, under product code NUC (Lubricant, Personal).

Who makes the Water-based lubricant?

Guangzhou Haoyimai Trading Co., Ltd., based in Guangzhou, is the applicant of record for K253983.

How long did the K253983 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Mar 6, 2026, 84 days later.

← All decisions in March 2026