510(k) Report

Devices descending from K113422

60 later devices reach Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.20260—
+1K212095SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V.20221—
+1K190183Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20191—
+1K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd.201812—
+1K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd.201732—
+1K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd.20154—
+1K130212Safety Hypodermic Needles with/Without SyringeWuxi Yushou Medical Applicances Co., Ltd.20130—
+1K122249Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation20124—
+2K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V.20250—
+2K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…Berpu Medical Technology Co., Ltd.20240—
+2K233037Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd.20230—
+2K231720Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+2K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20223—
+2K221079Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd.20221—
+2K221066Sterile Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+2K221080Sterile Safety Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+2K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd.20221—
+2K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20210—
+2K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc.20214—
+2K210232Sterile Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20210—
+2K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd202014—
+2K191644TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.20203—
+2K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd20207—
+2K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use…Gemtier Medical (Shanghai), Inc.20201—
+2K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe…Jiangsu Micsafe Medical Technology Co., Ltd.20190—
+2K152362Terumo SurGuard 3 Safety Hypodermic NeedleTerumo (Philippines) Corporation20151—
+3K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd.20260—
+3K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+3K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd.20250—
+3K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc.20240—
+3K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…Sol-Millennium Medical, Inc.20242—
+3K231519Revital CadyRevital Healthcare (Epz) Limited20230—
+3K231723Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+3K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+3K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd.20221—
+3K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc.20220—
+3K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+3K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+3K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+3K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device 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—
+3K213535Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+3K212652Sterile Syringe with Fixed Safety Needle for Single UseGemtier Medical (Shanghai), Inc.20220—
+3K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20213—
+3K211753Sterile Syringe With Safety NeedleJiangxi Hongda Medical Equipment Group, Ltd.20210—
+3K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+4K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.20260—
+4K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+4K250127TSK SyringeTsk Laboratory, Japan20250—
+4K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+4K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…Perfect Medical Industry (Vn) Co., Ltd.20241—
+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—
+4K221068Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+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—
+5K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…Exelint International, Co.20250—
+5K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—