510(k) Report

Devices descending from K002223

18 later devices reach Epic SPO2 Finger Sensor, Model E412-20 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082846Apk SPO2 Pulse Oximeter SensorAPK Technology Co., Ltd.20090—
+1K053420Tenacore SP02 SensorsTenacore Holdings, Inc.200616—
+2K082546Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips…Unimed Medical Supplies, Inc.200815—
+3K202851Spo2 SensorJkh USA, LLC20201—
+3K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+4K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+4K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+4K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+4K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+4K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+4K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+4K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+4K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+4K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+4K173045OximeterShenzhen Greatmade Tech Limited20180—
+5K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+5K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+5K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—