510(k) Report

Devices descending from K973516

2 later devices reach Capiox Hemoconcentrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243920Purema H Hemoconcentrator - PediatricMedica USA, Inc.20250—
+1K232171Purema® H Hemoconcentrator (EtO Sterilized)Tecnoideal America20240—