510(k) Report

Devices descending from K132429

6 later devices reach Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia… through their predicates, nearest generation first.

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