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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 / May 2026 / K252622

510(k) cleared

Male Latex Condom HA

Okamoto USA, Inc. · May 4, 2026 · K252622

FDA cleared the Male Latex Condom HA from Okamoto USA, Inc. on May 4, 2026 under K252622, a abbreviated 510(k). The device falls under product code HIS, Condom, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Aug 19, 2025. The decision came 258 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 Okamoto USA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252622?

K252622 is the FDA 510(k) for Male Latex Condom HA, submitted by Okamoto USA, Inc.. FDA's decision date was May 4, 2026, under product code HIS (Condom).

Who makes the Male Latex Condom HA?

Okamoto USA, Inc., based in Sandusky, OH, is the applicant of record for K252622.

How long did the K252622 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on May 4, 2026, 258 days later.

← All decisions in May 2026