FDA.report

510(k) K252228

Device
Seaman Pro/Seaman
Applicant
Checkcells, Inc.
510(k) number
K252228
Product code
POV
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-09
Date received
2025-07-16
Regulation
864.5220
Classification name
Semen Analysis Device
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Martin Kosela
Address
1725 Ocean Front Walk Unit 713 Santa Monica CA US 90401 90401

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code POV

510(k)DeviceApplicantDecision date
K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.2025-05-30
K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.2025-05-09
K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems , Ltd.2025-05-02
K241628YO Home Sperm TestMedical Electronic Systems , Ltd.2024-11-29
K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems , Ltd.2023-08-07
K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.2020-10-28
K183602SwimCount Sperm Quality TestMotilitycount Aps2019-06-27
K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd.2018-11-16
K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc.2017-11-17
K161493YO Home Sperm TestMedical Electronic Systems , Ltd.2016-11-08
K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc.2016-05-16
K100341SPERMCHECK FERTILITYPrinceton BioMeditech Corp.2010-05-04
K073039SPERMCHECK VASECTOMYPrinceton BioMeditech Corp.2008-01-24
K071737GENERAL SEMEN ANALYSIS KITDyn-Bioshaf (2006) , Ltd.2007-10-25
K063864QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSISMedical Electronic Systems , Ltd.2007-03-26