510(k) Report

Devices descending from K922522

29 later devices reach Monoject Safety Syringe, 1 CC, 3CC and 12 CC Sizes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140949Ulticare Safety Syringe with Removable NeedleUltimed Incorporated20150—
+1K103011Ulticare Safety Insulin SyringeUlti-Med Intl., Inc.20111—
+1K080600Ultimed Ulticare Safety SyringeUltimed, Inc.20083—
+1K061492Monoject Magellan Insulin and Tuberculin Safety SyringeTyco Healthcare200620—
+1K991758Monoject Insulin SyringeThe Kendal Co.19993—
+2K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeCMT Health PTE., Ltd.20260—
+2K231907Medline Safety Insulin and TB SyringesMedline Industries, LP20230—
+2K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…Cardinal Health200, LLC20230—
+2K160589Certa Dose PD Epinephrine 1mg/mL IM/SC SyringeCerta Dose, Inc.20170—
+2K150758Safelock Disposable Insulin SyringeJiangyin Caina Technology Co., Ltd.20150—
+2K132681Sol-Guard Insulin and Tuberculin Safety SyringeSol-Millennium Medical, Inc.201416—
+2K081547Bio-Med Soft Insulin Syringe: Models 1CC, 0.5CC, 0.3CCBio-Med USA, Inc.20080—
+2K033373Monoject Insulin SyringeTyco Healthcare200301
+3K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd202014—
+3K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety…Jiangsu Caina Medical Co.,Ltd20190—
+4K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+4K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+4K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+4K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd.20220—
+4K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…Anhui Tiankang Medical Technology Co., Ltd.20220—
+4K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+5K250127TSK SyringeTsk Laboratory, Japan20250—
+5K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+5K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd20241—
+5K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+5K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+5K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+6K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+6K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—