510(k) Report

Devices descending from K992101

6 later devices reach Criterion 40 or PM 40 through their predicates, nearest generation first.

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