510(k) Report

Devices descending from K011283

3 later devices reach Monoject Prefill 0.9% Sodium Chloride Flush Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032438Modification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill…Tyco Healthcare20042Class I
+2K090882Flush Syringe Filled with 0.9% Sodium ChlorideHospira, Inc.201003
+2K060339Kendall Monoject Pre-Fill Advanced 0.9%Sodium Chloride Flush Syringes for Sterile DeliveryTyco Healthcare/Kendall2006011