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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 / April 2026 / K252228

510(k) cleared

Seaman Pro/Seaman

Checkcells, Inc. · Apr 9, 2026 · K252228

FDA cleared the Seaman Pro/Seaman from Checkcells, Inc. on Apr 9, 2026 under K252228, a traditional 510(k). The device falls under product code POV, Semen Analysis Device, regulated at 21 CFR 864.5220 as a Class 2 device. The review panel was Hematology.

FDA logged the submission as received on Jul 16, 2025. The decision came 267 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 Checkcells, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252228?

K252228 is the FDA 510(k) for Seaman Pro/Seaman, submitted by Checkcells, Inc.. FDA's decision date was Apr 9, 2026, under product code POV (Semen Analysis Device).

Who makes the Seaman Pro/Seaman?

Checkcells, Inc., based in Santa Monica, CA, is the applicant of record for K252228.

How long did the K252228 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Apr 9, 2026, 267 days later.

← All decisions in April 2026