510(k) Report

Devices descending from K962156

40 later devices reach 3304 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070732Bci Autocon 3304 Digital Pulse OximeterSmiths Medical Pm, Inc.200728—
+1K041522Flexi-Stat Disposable Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20042—
+1K041964Mediaid Reusable Finger Clip SPO2 Sensors and Disposable Non-Adhesive Sensors and…Mediaid, Inc.20040—
+1K041647Flexi-Stat Reusable Finger Clip SPO2 Sensors (Nellcor-Compatible),(Bci-Compatible)…Elekon Industries U.S.A., Inc.20042—
+1K041644Flexi-Stat Disposable Non-Adhesive SPO2 Sensors, (Nellcor-Compatible), (Bci-Compatible)…Elekon Industries U.S.A., Inc.20040—
+1K020350Bci 3180 Pulse OximeterBci, Inc.200202
+1K9914103402 Handheld Pulse OximeterBci Intl., Inc.199928—
+1K971946NPB-190 Pulse Oximeter (NPB-190)Nellcor Puritan Bennett, Inc.19971—
+2K083557Bci WW1030 Pulse OximeterSmiths Medical Pm, Inc.20090—
+2K083787Bci WW1000 Pulse Oximeter, Model WW1000Smiths Medical Pm, Inc.20090—
+2K083705Bci WW1020 Pulse Oximeter, Model WW1020Smiths Medical Pm, Inc.200925—
+2K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc.20060—
+2K061191Finger and Ear Sensors and Neonatal-Adult and Adult/Pediatric Adhesive Sensors for Use…Measurement Specialties, Inc.20060—
+2K042705Disposable Non-Adhesive SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+2K042704Reusable Finger Clip SPO2 SensorsElekon Industries U.S.A., Inc.20041—
+3K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—
+3K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc.201022—
+3K093080Metaphor Metabolic MonitorTreymed, Inc.20100—
+4K173368Reusable & Disposable SpO2 SensorsShenzhen Coreray Technology, Ltd.20180—
+4K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd.20175—
+4K152390Medke Oximetry Finger SensorShenzhen Medke Technology Co., Ltd.20160—
+4K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc.201514—
+5K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.20260—
+5K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…Unimed Medical Supplies, Inc.20250—
+5K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…Unimed Medical Supplies, Inc.20250—
+5K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…Unimed Medical Supplies, Inc.20250—
+5K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…Unimed Medical Supplies, Inc.20250—
+5K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc.20251—
+5K202851Spo2 SensorJkh USA, LLC20201—
+5K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd.20201—
+5K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd.20191—
+5K191420Reusable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20190—
+5K181270Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc.20181—
+5K172981Reusable SpO2 Sensors, Disposable SpO2 SensorsAPK Technology Co., Ltd.20180—
+5K173045OximeterShenzhen Greatmade Tech Limited20180—
+6K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.20260—
+6K251751Spo2 Sensor CSS032DShenzhen Ykd Technology Co., Ltd.20250—
+6K231979Mecun SpO2 sensorShenzhen Mecun Medical Supply Co., Ltd.20240—
+6K200069Disposable SpO2 SensorShenzhen Changke Connect Electronics Co., Ltd.20200—
+6K192608Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd20200—