510(k) Report

Devices descending from K240149

2 later devices reach Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242107CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC)…Casebioscience, Inc.20251—
+2K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.20260—