510(k) Report

Devices descending from K061492

20 later devices reach Monoject Magellan Insulin and Tuberculin Safety Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.20260—
+1K231907Medline Safety Insulin and TB SyringesMedline Industries, LP20230—
+1K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…Cardinal Health200, LLC20230—
+1K132681Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc.201416—
+2K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd202014—
+2K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety…Jiangsu Caina Medical Co.,Ltd20190—
+3K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+3K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+3K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+3K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd.20220—
+3K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…Anhui Tiankang Medical Technology Co., Ltd.20220—
+3K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+4K250127TSK SyringeTsk Laboratory, Japan20250—
+4K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+4K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd20241—
+4K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+4K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+4K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+5K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+5K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—