510(k) Report

Devices descending from K192414

3 later devices reach Praxiject 0.9% NaCl through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231754Praxiject™ 0.9% NaClMedxl, Inc.20231—
+1K214080PentaflushPentaferte Italia S.R.L.20220—
+2K233623Praxiject™ SP 0.9% NaClMedxl, Inc.20240—