510(k) Report

Devices descending from K944355

43 later devices reach Nipro Branded Disposable Syringes, Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130049Monoject 12ML SyringeNipro Medical Corporation20130—
+1K091279Nipro Disposable SyringeNipro Medical Corporation20090—
+1K052474Nipro Hypodermic NeedleNipro Medical Corp.200513—
+1K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp.200510—
+1K030683Nipro Disposable SyringesNipro Medical Corp.200323—
+1K013293Nipro Hypodermic NeedleNipro Medical Corp.20013—
+2K102584Imc Hypodermic NeedleInternational Medsurg Connection20111220
+2K072654Patient Safe SyringeRetractable Technologies, Inc.20070—
+2K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc.200732
+2K063280Injekt SyringeB.Braun Medical, Inc.200682
+2K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069—
+2K061039Amsure Disposable Syringe with/Without NeedleAmsino International, Inc.20060—
+2K060002Ritract Safety SyringeRitract, Ltd.20060—
+2K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc.20050—
+2K021224Endocervical Block NeedleWallach Surgical Devices, Inc.20021—
+3K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+3K231558SMB Luer lock disposable syringeSmb Corporation of India20240—
+3K222925Hypodermic Syringes & NeedleLifelong Meditech Private Limited20230—
+3K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+3K172483Kopac Sterile NeedlePoonglim Pharmatech, Inc.20188—
+3K180259Sterile Hypodermic Needle for Single UseJiangsu Shenli Medical Production Co., Ltd.20180—
+3K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemSwan Valley Medical, Incorporated20120—
+3K101547Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH20103—
+3K073206Needle-Trap/Needle Safety LabelSchreiner Medipharm20080—
+3K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc.20077—
+3K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc20050—
+4K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.20215—
+4K202432MiniLoad SyringeOcuject, LLC20212—
+4K192222EZ-Inject Single use NeedlePoonglim Pharmatech, Inc.20207—
+4K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc.20080—
+5K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.20244—
+5K212544MiniLoad SyringeOcuject, LLC20210—
+5K210444EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc.20216—
+6K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+6K250284TSK SELECT™ NeedleTsk Laboratory, Japan20250—
+6K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc.20242—
+6K231734STERiJECT Low Dead Space, STERiJECT The Invisible NeedleTsk Laboratory International Japan KK20240—
+6K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+6K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+6K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+7K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+7K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+7K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—