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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K252228
Device Name Seaman Pro/Seaman
Applicant
Checkcells, Inc.
1725 Ocean Front Walk
Unit 713
Santa Monica,  CA  90401
Applicant Contact Martin Kosela
Correspondent
Checkcells, Inc.
1725 Ocean Front Walk
Unit 713
Santa Monica,  CA  90401
Correspondent Contact Martin Kosela
Regulation Number864.5220
Classification Product Code
POV  
Date Received07/16/2025
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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