510(k) Report

Devices descending from K082837

9 later devices reach Sterile Field Saline Pre-Filled Syringe (S) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171109Praxiject 0.9% NaClMedxl, Inc.20176—
+1K1426200.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride…Excelsior Medical Corporation201401
+1K101270Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311Excelsior Medical Corp.20110—
+2K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…Nurse Assist, LLC20201Class I
+2K192414Praxiject 0.9% NaClMedxl, Inc.20203—
+3K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.20250—
+3K231754Praxiject™ 0.9% NaClMedxl, Inc.20231—
+3K214080PentaflushPentaferte Italia S.R.L.20220—
+4K233623Praxiject™ SP 0.9% NaClMedxl, Inc.20240—