510(k) Report

Devices descending from K072816

9 later devices reach Niox Mino through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.201921
+1K101034Niox Mino Model 09-1000Aerocrine AB20105—
+2K213611Fenom ProCaire Diagnostics, Inc.20231—
+2K133898Niox Vero Airway Inflammation MonitorAerocrine AB20143—
+2K123683Niox Panel for Use with the Niox Mino Airway Inflammation MonitorAerocrine AB20120—
+3K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation20250—
+3K150233NIOX VERO Airway Inflammation MonitorAerocrine AB20152—
+4K170983Niox VeroCircassia AB20171—
+5K203695NObreath®Bedfont Scientific, Ltd.20210—