510(k) Report

Devices descending from K101034

5 later devices reach Niox Mino Model 09-1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133898Niox Vero Airway Inflammation MonitorAerocrine AB20143—
+1K123683Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB20120—
+2K150233NIOX VERO Airway Inflammation MonitorAerocrine AB20152—
+3K170983Niox VeroCircassia AB20171—
+4K203695NObreath®Bedfont Scientific, Ltd.20210—