510(k) Report

Devices descending from K141311

3 later devices reach 0.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company201723
+2K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company20250—
+2K2139550.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company20220—