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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 / K253525

510(k) cleared

Urocross Expander System (Model Numbers ES2018 and ES3025)

Prodeon Medical, Inc. · Mar 12, 2026 · K253525

FDA cleared the Urocross Expander System (Model Numbers ES2018 and ES3025) from Prodeon Medical, Inc. on Mar 12, 2026 under K253525, a traditional 510(k). The device falls under product code QKA, Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia, regulated at 21 CFR 876.5510 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Nov 13, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Prodeon Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K261342 (Urocross Expander System (UES-2018-C1)), K252572 (Prodeon Urethral Sheath System).

Questions & Answers

What did FDA clear under K253525?

K253525 is the FDA 510(k) for Urocross Expander System (Model Numbers ES2018 and ES3025), submitted by Prodeon Medical, Inc.. FDA's decision date was Mar 12, 2026, under product code QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia).

Who makes the Urocross Expander System (Model Numbers ES2018 and ES3025)?

Prodeon Medical, Inc., based in Sunnyvale, CA, is the applicant of record for K253525.

How long did the K253525 review take?

FDA received the submission on Nov 13, 2025 and issued its decision on Mar 12, 2026, 119 days later.

← All decisions in March 2026

Sources