510(k) Report

Devices descending from K030683

23 later devices reach Nipro Disposable Syringes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072654Patient Safe SyringeRetractable Technologies, Inc.20070—
+1K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069—
+1K060002Ritract Safety SyringeRitract, Ltd.20060—
+1K051574Nipro Disposable Syringe with or Without NeedleNipro Medical Corp.200510—
+2K073206Needle-Trap/Needle Safety LabelSchreiner Medipharm20080—
+2K071459B. Braun Piston Syringes and Omnican and Omnifix Insulin SyringesB.Braun Medical, Inc.200732
+2K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc.20077—
+2K063280Injekt SyringeB.Braun Medical, Inc.200682
+2K061039Amsure Disposable Syringe with/Without NeedleAmsino International, Inc.20060—
+3K241385Omnifix Syringe NRFitB.Braun Medical, Inc.20240—
+3K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.20215—
+3K193101Omnifix Low Dead Space Luer Lock SyringeB.Braun Medical, Inc.20200—
+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—
+3K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc.20080—
+4K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.20244—
+4K202432MiniLoad SyringeOcuject, LLC20212—
+5K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+5K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc.20242—
+5K231558SMB Luer lock disposable syringeSmb Corporation of India20240—
+5K212544MiniLoad SyringeOcuject, LLC20210—
+6K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+6K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—