510(k) Report

Devices descending from K021746

9 later devices reach Sqa V, Sperm Quality Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243114SQA-iOw Sperm Quality AnalyzerMedical Electronic Systems, Ltd.20250—
+1K241628YO Home Sperm TestMedical Electronic Systems, Ltd.20240—
+1K220828SQA-iO Sperm Quality AnalyzerMedical Electronic Systems, Ltd.20230—
+1K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality AnalyzerBonraybio Co., Ltd.20184—
+1K161493YO Home Sperm TestMedical Electronic Systems, Ltd.20161—
+2K252228Seaman Pro/SeamanCheckcells, Inc.20260—
+2K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.20202—
+3K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality AnalyzerBonraybio Co., Ltd.20250—
+3K242388LensHooke X12 PRO Semen Analysis SystemBonraybio Co., Ltd.20250—