510(k) Report

Devices descending from K033325

3 later devices reach Ambit Continuous Ambulatory Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140783Halo Ambulatory Infusion SystemZyno Medical, LLC20141Class I
+1K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.200504
+2K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC20160Class I