510(k) Report

Devices descending from K050134

6 later devices reach Icc Insulin Safepro Safety Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited20082—
+1K062780Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd.20070—
+1K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.20061—
+2K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited20101—
+2K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+3K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited20100—