510(k) Report

Devices descending from K871083

7 later devices reach CM 5000 Monitor Airway Pressure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992101Criterion 40 or PM 40Caradyne, Ltd.20006—
+2K221734Maxtec MaxO2 ME+pMaxtec, LLC20232—
+2K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.20190—
+2K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC20180—
+2K122627Gio Digital Pressure GuagesGalemed Corp.20130—
+3K251245OxyMinder Pro (10310)Bio-Med Device, Inc.20250—
+3K231895Maxtec MaxBlend2+pMaxtec, LLC20230—