510(k) Report

Devices descending from K943836

4 later devices reach Pre-Filled 10CC Inflation Syringe W/Sterile Water through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030813Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile…Primary Care Solutions, Inc.20033Class I
+2K202698Prefilled SyringeHangzhou Primecare Medical Co., Ltd.20200—
+2K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, Inc.20181—
+3K200556AquaFlate Pre-Filled Sterile Water Syringe 10mLH R Pharmaceuticals, Inc.20200—