510(k) · Hematology

Seaman Pro/Seaman

by Checkcells, Inc.

Seaman Pro/Seaman is an AI-enabled medical device from Checkcells, Inc. that the U.S. FDA cleared through 510(k) K252228 on April 9, 2026. Its lead review panel is Hematology and its primary product code is POV (Semen Analysis Device).

See also all FDA AI clearances in 2026, top hematology AI devices.

Key facts

Submission numberK252228
Pathway510(k)
Date of final decision
Company (FDA list)Checkcells, Inc.
Lead review panelHematology
Primary product codePOV — Semen Analysis Device
Applicant (openFDA)Checkcells, Inc.
Applicant locationSanta Monica, CA, US
Device classClass 2
Regulation number21 CFR 864.5220
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Seaman Pro/Seaman went through this pathway (K252228).

openFDA lists it as a Class 2 device under 21 CFR 864.5220. Class II devices are moderate risk and are subject to general and special controls.

Product code POV covers 5 devices on the FDA AI list. By decision date, this device is #5 of 5 under that code. Checkcells, Inc. has 1 AI-enabled device on the list, and the Hematology panel accounts for 22 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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