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..
Summary
The Seaman Pro/Seaman was filed under product code POV — a hematology-panel code covering sperm analysis devices. "Seaman" plays on the semen-analysis indication. POV is a small category with a limited predicate set and a mix of clinical-lab and at-home products.
Hematology panel, Traditional 510(k). At-home semen analysis has become an increasingly active filing area over the last five years with consumer-adjacent diagnostic companies entering the space; the "Pro" variant likely targets clinical labs while the consumer version targets direct-to-consumer distribution.
Checkcells, Inc. files from Santa Monica, CA. Nine-month review clock, on the longer end — possibly reflecting new-indication discussions or labeling review for consumer use.
Clearance details
- Applicant
- Checkcells, Inc.
- Product code
- Code POV
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.