510(k) Report

Devices descending from K021089

13 later devices reach Oximax Max-Fast Adhesive Forehead Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+1K051271Oximax Neomax Adhesive Forehead Reflectance Oximetry SensorNellcor Puritan Bennett, Inc.20060—
+1K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-PNellcor Puritan Bennett, Inc.20053—
+1K050583Model 250 Series Maternal/Fetal MonitorGe Medical Systems Information Technologies20051—
+1K032551Masimo Lnop-TF-I Resuable Transflectance SensorMasimo Corp.20041—
+2K181738Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsSurgical Instrument Service and Savings Inc (Dba Medline20191—
+2K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation20160—
+2K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+2K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+2K072976Model 250CX Series Maternal/Fetal MonitorGE Healthcare20070—
+3K201699Medline ReNewal Reprocessed Nellcor OxiMax SpO2 SensorSurgical Instrument and Savings Inc (Dba Medline Renewal)20200—
+3K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+4K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—