Seaman Pro/Seaman— 510(k) K252228
Substantially EquivalentCheckcells, 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). Semen analysis has drawn more consumer-focused filings in recent years, and home-use claims tend to add review time.
Clearance details
- Applicant
- Checkcells, Inc.
- Product code
- 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
Recent devices under product code POV
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