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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 / July 2026 / K253662

510(k) cleared

LIXI (LXOSFM1)

Luwi, LLC · Jul 14, 2026 · K253662

FDA cleared the LIXI (LXOSFM1) from Luwi, LLC on Jul 14, 2026 under K253662, a traditional 510(k). The device falls under product code MSC, Barrier, Std, Oral Sex, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 20, 2025. The decision came 236 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 Luwi, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253662?

K253662 is the FDA 510(k) for LIXI (LXOSFM1), submitted by Luwi, LLC. FDA's decision date was Jul 14, 2026, under product code MSC (Barrier, Std, Oral Sex).

Who makes the LIXI (LXOSFM1)?

Luwi, LLC, based in Mount Prospect, IL, is the applicant of record for K253662.

How long did the K253662 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Jul 14, 2026, 236 days later.

← All decisions in July 2026