510(k) Report

Devices descending from K922974

511 later devices reach Portable Patient Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+10K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+10K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+11K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+12K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—
+12K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—