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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 / K252158

510(k) cleared

Sagami Original 002 Polyurethane Male Condom

Mayer Laboratories · Mar 30, 2026 · K252158

FDA cleared the Sagami Original 002 Polyurethane Male Condom from Mayer Laboratories on Mar 30, 2026 under K252158, a traditional 510(k). The device falls under product code MOL, Condom, Synthetic, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jul 9, 2025. The decision came 264 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 Mayer Laboratories in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252158?

K252158 is the FDA 510(k) for Sagami Original 002 Polyurethane Male Condom, submitted by Mayer Laboratories. FDA's decision date was Mar 30, 2026, under product code MOL (Condom, Synthetic).

Who makes the Sagami Original 002 Polyurethane Male Condom?

Mayer Laboratories, based in Berkeley, CA, is the applicant of record for K252158.

How long did the K252158 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Mar 30, 2026, 264 days later.

← All decisions in March 2026