510(k) Report

Devices descending from K041399

11 later devices reach Hypodermic Needle-Pro Edge Needle Protection Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc.20077—
+1K063450Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910…Smiths Medical Asd, Inc.20078—
+1K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069—
+2K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.20215—
+2K073188Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc.20080—
+2K073206Needle-Trap/Needle Safety LabelSchreiner Medipharm20080—
+3K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.20244—
+4K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+4K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc.20242—
+5K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.20260—
+5K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—