510(k) Report

Devices descending from K800560

6 later devices reach MX820-5 Pressure Infusor 500CC MX820-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K9904471000 Pressure Infusion Sigmacon 1000Valley West, Inc.19990—
+1K9800893600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc.19981—
+1K973133Big Bag 3000 Pressure InfusorByron Medical19975—
+2K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical19982—
+3K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC20161—
+4K230083SafiraMedovate Limited20230—