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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 / K252005

510(k) cleared

Livi Device

Liviwell, Inc. · Mar 20, 2026 · K252005

FDA cleared the Livi Device from Liviwell, Inc. on Mar 20, 2026 under K252005, a traditional 510(k). The device falls under product code HEB, Tampon, Menstrual, Unscented, regulated at 21 CFR 884.5470 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 27, 2025. The decision came 266 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 Liviwell, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252005?

K252005 is the FDA 510(k) for Livi Device, submitted by Liviwell, Inc.. FDA's decision date was Mar 20, 2026, under product code HEB (Tampon, Menstrual, Unscented).

Who makes the Livi Device?

Liviwell, Inc., based in Mountain Lakes, NJ, is the applicant of record for K252005.

How long did the K252005 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Mar 20, 2026, 266 days later.

← All decisions in March 2026