510(k) Report

Devices descending from K082818

6 later devices reach Subcutaneous Needle Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…Repro-Med Systems, Inc. Dba Rms Medical Products201302
+1K120195Safety Subcutaneous Tissue Infusion SetMulti Med20120—
+1K120395Neria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V.201201
+1K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc.20113—
+2K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC20210—
+2K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp20120—