510(k) Report

Devices descending from K961474

20 later devices reach Polyfin Infusion Set MMT-106/MMT-107/MMT-133 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020530Evans Sub-Q, Model MC4206Evans Medical, Inc.200217—
+1K964456Polyfin QR with Wings Infusion Sets, Models 365, 366, and 367Medtronic Minimed19970—
+1K964455Polyfin with Wings Infusion Sets, Models 306, 307, 333Medtronic Minimed19970—
+2K140131Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation20148—
+2K122404Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614…Repro-Med Systems, Inc. Dba Rms Medical Products201302
+2K121092Flowease [Subcutaneous] Infusion SetBaxter Healthcare Corp20120—
+2K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc.20113—
+2K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc.20086—
+2K042666Luth-All Sub-Q Needle SetLuth-All Medical Products, LLC20040—
+3K202279Insignis Subcutaneous Needle SetsInnovative Health Sciences, LLC20210—
+3K201626Safety Subcutaneous Infusion SetEpic Medical Pte., Ltd.20210—
+3K142319SCIg60 Infuser, InfusetEmed Technologies Corporation20156—
+3K120195Safety Subcutaneous Tissue Infusion SetMulti Med20120—
+3K120395Neria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V.201201
+4K161906SCIg60 InfuserEmed Technologies Corporation20165—
+5K222087SCIg60 Infusion SystemEmed Technologies Corporation20223—
+5K173783SCIg60 Infusion SystemEmed Technologies Corporation20180—
+6K240148SCIg60 Infusion SystemEmed Technologies Corporation20241—
+6K230883VersaPump Infusion SystemEmed Technologies Corporation20230—
+7K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation20250—