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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 / January 2026 / K253285

510(k) cleared

Elitone for Men

Elidah, Inc. · Jan 23, 2026 · K253285

FDA cleared the Elitone for Men from Elidah, Inc. on Jan 23, 2026 under K253285, a traditional 510(k). The device falls under product code QAJ, Cutaneous Electrode Stimulator For Urinary Incontinence, regulated at 21 CFR 876.5330 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 29, 2025. The decision came 116 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 Elidah, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253285?

K253285 is the FDA 510(k) for Elitone for Men, submitted by Elidah, Inc.. FDA's decision date was Jan 23, 2026, under product code QAJ (Cutaneous Electrode Stimulator For Urinary Incontinence).

Who makes the Elitone for Men?

Elidah, Inc., based in Newtown, CT, is the applicant of record for K253285.

How long did the K253285 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jan 23, 2026, 116 days later.

← All decisions in January 2026