510(k) Report

Devices descending from K102512

3 later devices reach RMS Subcutaneous Needle Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC20210—
+1K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…Repro-Med Systems, Inc. Dba Rms Medical Products201302
+1K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp20120—