510(k) Report

Devices descending from K101031

5 later devices reach Masimo Disposable Oximetry Ear Sensor, Model E1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121912E1 Ear SensorsMasimo Corporation20124—
+2K122996Assurance Alar Sensor Model 10078; AB-N Adapter Cable Model 10085Xhale20133—
+3K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+4K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+5K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—