510(k) Report

Devices descending from K923139

9 later devices reach Hemocor HP Hemoconcentrator Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123288HemoconcentratorMaquet Cardiopulmonary, AG20130—
+1K021732DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…Dideco S.P.A.20022—
+1K974584Fresenius F Series Hemoconcentrators F400,F500,F700,F800,F400TS,F500TS,F700S,F800TSFresenius USA, Inc.19981—
+1K973516Capiox HemoconcentratorTerumo Medical Corp.19982—
+2K243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.20250—
+2K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14…Sorin Group Italia S.R.L.20250—
+2K232171Purema® H Hemoconcentrator (EtO Sterilized)Tecnoideal America20240—
+2K081313SH14 HemoconcentratorSorin Group Italia S.R.L.20081—
+2K992275Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol…Fresenius USA, Inc.19990—