510(k) Report

Devices descending from K950821

512 later devices reach HP M1205A Omnicare Component Transport Monitoring System Model 24 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+11K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+11K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+11K213515WesperO2Wesper, Inc.20220—
+11K143216Assurance Alar / Nasal SpO2 SensorXhale, Inc.201521
+12K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—
+12K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+12K171423Nasal Alar SpO2 SensorXhale, Inc.201711
+13K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…Philips Medizin Systeme20260—