510(k) Report

Devices descending from K811986

2 later devices reach The Amp 80/2 Pediatric Cycler System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041792Fresenius Staysafe Patient Connectors, Model 050-87211Fresenius Medical Care North America20041—
+2K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetFresenius Medical Care Renal Therapies Group, LLC201801