510(k) Report

Devices descending from K041738

5 later devices reach Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071222Infusor SV and LV Elastomeric Infusion DevicesBaxter Healthcare Corp200744
+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—