510(k) Report

Devices descending from K002380

7 later devices reach Infusor SV, Infusor LV, Baxter Pain Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071222Infusor SV and LV Elastomeric Infusion DevicesBaxter Healthcare Corp200744
+1K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.20060—
+1K041738Baxter Infusor SV (Small Volume); Baxter Infusor LV (Large Volume)Baxter Healthcare Corporation20045—
+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—