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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 / June 2026 / K254011

510(k) cleared

Flow Water-Based Personal Lubricant

LBDO Group, Inc. · Jun 22, 2026 · K254011

FDA cleared the Flow Water-Based Personal Lubricant from LBDO Group, Inc. on Jun 22, 2026 under K254011, 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 15, 2025. The decision came 189 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 LBDO Group, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254011?

K254011 is the FDA 510(k) for Flow Water-Based Personal Lubricant, submitted by LBDO Group, Inc.. FDA's decision date was Jun 22, 2026, under product code NUC (Lubricant, Personal).

Who makes the Flow Water-Based Personal Lubricant?

LBDO Group, Inc., based in Brooklyn, NY, is the applicant of record for K254011.

How long did the K254011 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jun 22, 2026, 189 days later.

← All decisions in June 2026