510(k) Report

Devices descending from K831004

10 later devices reach Automated 8400 Blood Cell Separator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172590Spectra Optia Apheresis SystemTerumobct, Inc.20182—
+1K132429Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…Terumobct, Inc.20136—
+2K183081Spectra Optia Apheresis SystemTerumobct, Inc.20190—
+2K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…Fresenius Kabi USA,Llc201824
+2K181049Spectra Optia Apheresis SystemTerumobct, Inc.20180—
+2K141938Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)Terumobct, Inc.20152—
+3K192150AMICUS Separator SystemFresenius Kabi AG20191—
+3K151368Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…Terumo Bct20151—
+4K200530AMICUS Separator SystemFresenius Kabi AG20200—
+4K153601Spectra Optia Apheresis SystemTerumobct, Inc.20160—