510(k) Report

Devices descending from K012646

83 later devices reach Terumo 30 Gauge Hypodermic Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121607Terumo (R) NeedleTerumo (Philippines) Corporation201209
+1K073122Monoject Hypodermic Needle, Model 250, 30 Gauge Hypodermic NeedleCovidien Lp, Formerly Registered AS Tyco Healthcar20070—
+1K06260829G and 30G K-Pack II NeedleTerumo Europe N.V.200610—
+1K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp.200467—
+1K021224Endocervical Block NeedleWallach Surgical Devices, Inc.20021—
+2K110850K-Pack II Needle- 27G & 30G Thin WallTerumo Europe N.V.20115—
+2K082908Novaguard, Model 3611001West Pharmaceutical Services, Inc.20090—
+2K082820K-Pack II Needle - 29G Thin WallTerumo Europe N.V.20089—
+2K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc20050—
+2K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp.200565—
+3K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)Terumo Europe N.V.20250—
+3K222681Altaviz Needle KitAltaviz, LLC202211
+3K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin…Terumo Europe N.V.20192—
+3K190183Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20191—
+3K151398K-Pack II Needle - 29G x 5/16 Thin WallTerumo Europe N.V.20150—
+3K132233K-Pack II Needle - 27G X 3/4 Thin WallTerumo Europe N.V.20130—
+3K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation201260—
+3K110527K-Pack Surshield Needle, Hypodermic Needle for Single UseTerumo Europe N.V.20113—
+4K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.20260—
+4K230951Terumo Injection Filter Needle (NF-3013RBKE05M)Terumo Europe N.V.20231—
+4K231261Altaviz Needle Kit IIAltaviz, LLC20230—
+4K212095SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V.20221—
+4K211555Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20210—
+4K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…Berpu Medical Technology Co., Ltd.201812—
+4K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd.201732—
+4K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd.20154—
+4K130212Safety Hypodermic Needles with/Without SyringeWuxi Yushou Medical Applicances Co., Ltd.20130—
+4K122249Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation20124—
+4K11179727 G X 1/2 K-Pack Surshield NeedleTerumo Europe N.V.20112—
+5K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)Terumo Europe N.V.20250—
+5K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)Terumo Europe N.V.20250—
+5K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK20240—
+5K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single…Berpu Medical Technology Co., Ltd.20240—
+5K233037Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Device Co., Ltd.20230—
+5K231720Sterile Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+5K223353DropSafeTM SicuraTMPikdare Spa20220—
+5K221247Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20223—
+5K221079Sterile Hypodermic Syringes for Single UseSichuan Prius Biotechnology Co., Ltd.20221—
+5K221066Sterile Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+5K221080Sterile Safety Hypodermic Needles for Single UseSichuan Prius Biotechnology Co., Ltd.20220—
+5K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for…Shandong Weigao Group Medical Polymer Co., Ltd.20221—
+5K211214Sterile Hypodermic Needles for Single UseAzur Medical Company, Inc.20214—
+5K210232Sterile Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20210—
+5K1925511ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety…Jiangsu Caina Medical Co.,Ltd202014—
+5K191644TK Safety NeedleAnhui Tiankang Medical Technology Co., Ltd.20203—
+5K193526Syringe with safety needle, Safety needleJiangsu Caina Medical Co.,Ltd20207—
+5K192679Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use…Gemtier Medical (Shanghai), Inc.20201—
+5K183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe…Jiangsu Micsafe Medical Technology Co., Ltd.20190—
+5K152362Terumo SurGuard 3 Safety Hypodermic NeedleTerumo (Philippines) Corporation20151—
+6K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd.20260—
+6K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+6K252631Profoject™ Disposable NeedleCMT Health PTE., Ltd.20250—
+6K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc.20240—
+6K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…Sol-Millennium Medical, Inc.20242—
+6K231519Revital CadyRevital Healthcare (Epz) Limited20230—
+6K231723Sterile Safety Hypodermic Needles for Single UseWepon Medical Technology Co., Ltd.20230—
+6K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+6K223334Sterile Hypodermic Needles for Single UseZhejiang Kindly Medical Devices Co., Ltd.20221—
+6K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc.20220—
+6K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+6K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+6K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+6K220603Disposable Medical Safety Hypodermic NeedleHantech Medical Device Co., Ltd.20220—
+6K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd.20220—
+6K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…Anhui Tiankang Medical Technology Co., Ltd.20220—
+6K213535Sterile Safety Hypodermic Needles for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+6K212652Sterile Syringe with Fixed Safety Needle for Single UseGemtier Medical (Shanghai), Inc.20220—
+6K211329Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…Jiangsu Kangbao Medical Equipment Co., Ltd.20213—
+6K211753Sterile Syringe With Safety NeedleJiangxi Hongda Medical Equipment Group, Ltd.20210—
+6K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+7K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.20260—
+7K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+7K250127TSK SyringeTsk Laboratory, Japan20250—
+7K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+7K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable…Perfect Medical Industry (Vn) Co., Ltd.20241—
+7K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd20241—
+7K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+7K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+7K221068Sterile Hypodermic Syringes for Single Use with NeedlesSichuan Prius Biotechnology Co., Ltd.20220—
+7K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+8K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+8K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe…Exelint International, Co.20250—
+8K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—