510(k) Report

Devices descending from K071222

4 later devices reach Infusor SV and LV Elastomeric Infusion Devices through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd.20163—
+2K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd.20260—
+2K240624InfuLifeFirst Medical Source, LLC20240—
+2K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd.20240—