510(k) Report

Devices descending from K894827

14 later devices reach Automix 3+3 Compounder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040456Fleboset MultipleLaboratorios Grifols, S.A.200411—
+1K961008Automix 3+3/as Compounder SystemBaxter Healthcare Corp199711
+2K243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals20250—
+2K102590Fleboset DoubleLaboratorios Grifols, S.A.20110—
+2K093182Set Gri-Fill 3.0Laboratorios Grifols, S.A.20101—
+2K082752QuickpinLaboratorios Grifols, S.A.20082—
+2K050339Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A.20056—
+2K041222Pinnacle TPN Management System Transfer SetB.Braun Medical, Inc.20040—
+3K170110Diana Medication Transfer SetIcu Medical, Inc.201811
+3K152441KIRO SetKiro Robotics S.L.20153—
+4K212530IVX Fluid Transfer SetOmnicell, Inc.202201
+4K203674B Dispensing LineAea Srl20210—
+4K190157Diana ChemoClave Transfer SetIcu Medical20190—
+4K162216Gri-Fill Peristaltic SetLaboratorios Grifols, S.A.20170—