510(k) Report

Devices descending from K002434

6 later devices reach Palm Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…Summit Medical Products, Inc.201705
+1K052221Ambit Push & Play Ambulatory Infusion PumpSorenson Medical, Inc.200504
+1K033325Ambit Continuous Ambulatory Infusion PumpSorenson Medical, Inc.200334
+1K033425Ambit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc.200301
+2K140783Halo Ambulatory Infusion SystemZyno Medical, LLC20141Class I
+3K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion…Zyno Medical, LLC20160Class I