510(k) Report

Devices descending from K061830

17 later devices reach Stat Profile Critical Care Xpress (CCX), Model 1+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110648Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation201116—
+2K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20230—
+2K200349Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+2K191626Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation20190—
+2K191365Stat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical Corporation20190—
+2K180340Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+2K180186Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+2K180428Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20182—
+2K173797Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20181—
+2K131703Nova Stat Profile Prime CCS Analyzer SystemNova Biomedical Corporation201431
+3K200403Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation202012
+3K200204Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+3K193246Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation20200—
+3K141907Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat…Nova Biomedical Corporation201501
+3K142220Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)Nova Biomedical Corporation201411
+4K252475ABL90 FLEX PLUS SystemRadiometer Medicals Aps20260—
+4K151982Stat Profile Prime ABG Analyzer SystemNova Biomedical Corporation201501