510(k) Report

Devices descending from K050770

6 later devices reach Modification to Accufuser, Accufuser Plus Standard Procedure Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc.20084Class I
+1K052451MPS Acacia Medflo Elastomeric PumpMps Acacia20055—
+2K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+3K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+3K240624InfuLifeFirst Medical Source, LLC20240—
+3K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—