510(k) Report

Devices descending from K121050

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company201611
+1K1413110.9% Sodium Chloride Injection, Usp BD Posiflush; SP Syringe, SF SyringeBecton, Dickinson and Company20143—
+2K2311610.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeBecton, Dickinson and Company20230—
+2K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company201723
+3K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company20250—
+3K2139550.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company20220—