DeviceClearance

Seaman Pro/Seaman— 510(k) K252228

Substantially Equivalent

Checkcells, Inc.

FDA 510(k) clearance K252228 for Seaman Pro/Seaman, Substantially Equivalent on 2026-04-09. Applicant: Checkcells, Inc.. Device class: 2.

Summary

Seaman Pro and Seaman are semen analysis devices, filed under POV, the product code for exactly that. The record lists two versions. "Pro" may mean a clinical version alongside a consumer one, but the record doesn't say.

Class II, 21 CFR 864.5220. The Hematology panel reviewed it as a Traditional 510(k).

Checkcells filed from Santa Monica, California. Review took 267 days (July 16, 2025 to April 9, 2026).

Clearance details

Applicant
Checkcells, Inc.
Product code
Product code POV
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Monica, CA, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.