510(k) Report

Devices descending from K151650

3 later devices reach SMARTez elastomeric infusion pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+1K240624InfuLifeFirst Medical Source, LLC20240—
+1K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—