Oximeter
FDA product code DQA · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular
726510(k) clearances
0PMA approvals
116recalls
Manufacturers
- Masimo Corporation 77
- Nonin Medical, Inc. 42
- Beijing Choice Electronic Technololgy Co., Ltd. 21
- Nellcor Puritan Bennett, Inc. 19
- Dolphin Medical, Inc. 12
- Nellcor, Inc. 11
- Bci Intl., Inc. 11
- Unimed Medical Supplies, Inc. 11
- Covidien LLC 10
- Beijing Choice Electronic Technology Co., Ltd. 10
- Epic Medical Equipment Services, Inc. 10
- Hewlett-Packard Co. 8
- Novametrix Medical Systems, Inc. 8
- Datex Division Instrumentarium Corp. 8
- Philips Medical Systems 8
- Shenzhen Creative Industry Co., Ltd. 7
- Envitec-Wismar GmbH 7
- Bci, Inc. 7
- Datex-Ohmeda, Inc. 7
- Taiwan Aulisa Medical Devices Technologies, Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | Philips Medizin Systeme Böblingen GmbH | 05/29/2026SE |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 05/11/2026SE |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional | Philips Medizin Systeme | 05/01/2026SE |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special | Unimed Medical Supplies, Inc. | 04/14/2026SE |
| K252448 | AViTA Pulse Oximeter (SP61)DQA · Traditional | Avita Corporation | 02/27/2026SE |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 02/17/2026SE |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional | Shenzhen Best Electronics Co., Ltd. | 01/07/2026SE |
| K251751 | Spo2 Sensor CSS032DDQA · Traditional | Shenzhen Ykd Technology Co., Ltd. | 12/19/2025SE |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/01/2025SE |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…DQA · Traditional | Unimed Medical Supplies, Inc. | 11/18/2025SE |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…DQA · Traditional | Unimed Medical Supplies, Inc. | 11/18/2025SE |
| K250837 | Pulse OximeterDQA · Traditional | Shanghai Berry Electronic Tech Co., Ltd. | 09/25/2025SE |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 08/13/2025SE |
| K241086 | Avidhrt Sense SpO2DQA · Traditional | Avidhrt, Inc. | 05/09/2025SE |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B)DQA · Traditional | Shenzhen Viatom Technology Co., Ltd. | 02/28/2025SE |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)DQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 02/25/2025SE |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…DQA · Traditional | Unimed Medical Supplies, Inc. | 02/20/2025SE |
| K242455 | AViTA Pulse Oximeter (SP62B)DQA · Traditional | Avita Corporation | 02/19/2025SE |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…DQA · Traditional | Unimed Medical Supplies, Inc. | 02/06/2025SE |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)DQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 01/30/2025SE |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)DQA · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 01/02/2025SE |
| K241090 | Evie Med RingDQA · Traditional | Movano Inc. Dba Movano Health | 11/29/2024SE |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B…DQA · Traditional | Shenzhen Smallsignal Technology Co., Ltd. | 11/21/2024SE |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112…DQA · Traditional | Shenzhen Yimi Life Technology Co., Ltd. | 10/25/2024SE |
| K234110 | Belun Ring BLR-200 (BLR-200)DQA · Traditional | Belun Technology Company Limited | 10/11/2024SE |
| K240808 | Pulse Oximeter (WS20A)DQA · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 10/03/2024SE |
| K233827 | OxiWearDQA · Traditional | Oxiwear, Inc. | 08/28/2024SE |
| K231979 | Mecun SpO2 sensorDQA · Traditional | Shenzhen Mecun Medical Supply Co., Ltd. | 08/16/2024SE |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse…DQA · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 07/01/2024SE |
| K232975 | Pulse Oximeter (MD300C228)DQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 06/21/2024SE |
| K240305 | ANNE LimbDQA · Traditional | Sibel Health, Inc. | 05/28/2024SE |
| K223399 | AViTA Pulse OximeterDQA · Traditional | Avita Corporation | 05/20/2024SE |
| K232495 | Sempulse Halo Vital Signs MonitorDQA · Traditional | Sempulse Corporation | 05/16/2024SE |
| K231288 | VyvoDQA · Traditional | Vyvo Technology Corp.(Vt) | 03/04/2024SE |
| K230277 | Pulse Oximeter(Model OHT60,OXH78)DQA · Traditional | Cofoe Medical Technology Co., Ltd. | 01/04/2024SE |
| K231531 | PediarityDQA · Traditional | Hinlab, Inc. | 12/21/2023SE |
| K223721 | Masimo StorkDQA · Traditional | Masimo Corporation | 12/15/2023SE |
| K230587 | Wrist Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 11/30/2023SE |
| K231243 | Finger Clip Pulse OximeterDQA · Traditional | Guangdong Genial Technology Co., Ltd. | 10/31/2023SE |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueDQA · Special | Masimo Corporation | 09/07/2023SE |
| K221361 | circul pro RingDQA · Traditional | Bodimetrics, LLC | 08/29/2023SE |
| K230172 | Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 08/12/2023SE |
| K211143 | Pulse OximeterDQA · Traditional | Shenzhen Brav Electronic Technologies Co., Ltd. | 07/17/2023SE |
| K222597 | BabySat 3DQA · Traditional | Owlet Babycare, Inc. | 06/16/2023SE |
| K221798 | Finger Pulse Oximeter, Model: X1906PDQA · Traditional | Shenzhen Changkun Technology Co., Ltd. | 05/04/2023SE |
| K213676 | Masimo Rad-G with TemperatureDQA · Traditional | Masimo Corporation | 04/16/2023SE |
| K220101 | Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 03/08/2023SE |
| K213431 | Handheld Pulse OximeterDQA · Traditional | Shenzhen Witleaf Medical Electronics Co., Ltd. | 02/26/2023SE |
| K222010 | Biobeat Platform-2 and BB-613WP PatchDQA · Traditional | Biobeat Technologies , Ltd. | 12/30/2022SE |
| K213430 | Fingertip Pulse OximeterDQA · Traditional | Shenzhen Witleaf Medical Electronics Co., Ltd. | 12/30/2022SE |
| K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…DQA · Traditional | Unimed Medical Supplies, Inc. | 12/19/2022SE |
| K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)DQA · Traditional | Shenzhen Zhengkang Technology Co., Ltd. | 12/16/2022SE |
| K221282 | Empatica Health Monitoring PlatformDQA · Traditional | Empatica S.r.l. | 11/20/2022SE |
| K220351 | Polso WatchDQA · Traditional | Chronisense Medical, Ltd. | 11/18/2022SE |
| K203812 | Oxyfit Pulse OximeterDQA · Traditional | Shenzhen Viatom Technology Co., Ltd. | 11/08/2022SE |
| K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3)DQA · Special | Shenzhen Imdk Medical Technology Co., Ltd. | 10/16/2022SE |
| K212385 | YUWELL Finger Pulse OximeterDQA · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 08/16/2022SE |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHbDQA · Special | Masimo Corporation | 08/04/2022SE |
| K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse…DQA · Traditional | Huizhou Xiaoou Technology Co., Ltd. | 06/22/2022SE |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemDQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 06/12/2022SE |
| K213515 | WesperO2DQA · Traditional | Wesper, Inc. | 06/10/2022SE |
| K212752 | Med-link Pulse OximeterDQA · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 05/20/2022SE |
| K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…DQA · Traditional | Covidien, LLC | 05/06/2022SE |
| K212153 | Biobeat Platform, BB-613WP PatchDQA · Traditional | Biobeat Technologies , Ltd. | 03/25/2022SE |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse…DQA · Traditional | Stryker Sustainability Solutions | 03/08/2022SE |
| K212300 | Pulse OximeterDQA · Traditional | Shenzhen Mericonn Technology Co., Ltd. | 02/25/2022SE |
| K211400 | Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 02/11/2022SE |
| K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…DQA · Traditional | Shenzhen Narig Bio-Medical Technology Co., Ltd. | 01/14/2022SE |
| K210305 | Pulse OximeterDQA · Traditional | Dongguan Lingxin Technologies Co., Ltd. | 12/22/2021SE |
| K211407 | Belun Ring BLR-100XDQA · Traditional | Belun Technology Company Limited | 10/21/2021SE |
| K212876 | Carescape SpO2 - MasimoDQA · Special | Masimo Corporation | 10/08/2021SE |
| K210032 | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)DQA · Special | Leadtek Research, Inc. | 09/01/2021SE |
| K210274 | Fingertip Pulse OximeterDQA · Traditional | Zhuhai Linte Medical Instrument Co., Ltd. | 07/30/2021SE |
| K201887 | VS Newborn Heart Rate MonitorDQA · Traditional | Surepulse Medical Limited | 07/23/2021SE |
| K203854 | Pulse OximeterDQA · Traditional | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 04/23/2021SE |
| K202776 | Fingertip pulse oximeterDQA · Traditional | Shenzhen Lepu Intelligent Medical Equipment Co.… | 03/01/2021SE |
| K202743 | Med-Link Temp-pulse OximeterDQA · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 03/01/2021SE |
| K201468 | Pulse OximeterDQA · Traditional | Shenzhen Creative Industry Co., Ltd. | 01/25/2021SE |
| K202324 | Fingertip Pulse OximeterDQA · Traditional | Shenzhen Bsx Technology Electronics Co., Ltd. | 12/14/2020SE |
| K202173 | Pulse OximeterDQA · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 12/07/2020SE |
| K201384 | Pulse OximeterDQA · Traditional | Shenzhen Raysintone Technology Co., Ltd. | 12/07/2020SE |
| K202851 | Spo2 SensorDQA · Traditional | Jkh USA, LLC | 11/27/2020SE |
| K201294 | Pulse OximeterDQA · Traditional | Guangdong Long Yao Electronic Technology Co., Ltd. | 11/27/2020SE |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorDQA · Special | Masimo Corporation | 09/24/2020SE |
| K200414 | Pulse OximeterDQA · Traditional | Shenzhen Aeon Technology Co., Ltd. | 09/23/2020SE |
| K201360 | Reusable and Disposable SpO2 SensorsDQA · Traditional | Xinkang Medical Instrument Co. , Ltd. | 08/19/2020SE |
| K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableDQA · Traditional | Covidien, LLC | 07/20/2020SE |
| K200537 | OxxiomDQA · Traditional | True Wearables, Inc. | 07/03/2020SE |
| K192900 | H500 Multi-Sensing Oximetry SystemDQA · Traditional | Nonin Medical, Inc. | 06/29/2020SE |
| K193350 | Leadtek Fingertip Pulse OximeterDQA · Traditional | Leadtek Research, Inc. | 04/27/2020SE |
| K191574 | OxSAT 100DQA · Traditional | S.L.P. , Ltd. | 04/09/2020SE |
| K200069 | Disposable SpO2 SensorDQA · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 03/13/2020SE |
| K192608 | Disposable SpO2 SensorDQA · Traditional | Shenzhen Sino-K Medical Technology Co.,Ltd | 01/24/2020SE |
| K192343 | Patient MonitorDQA · Traditional | Shenzhen Creative Industry Co., Ltd. | 12/31/2019SE |
| K191403 | Pulse OximeterDQA · Traditional | Nonin Medical, Inc. | 12/20/2019SE |
| K191279 | Disposable SpO2 SensorDQA · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 12/06/2019SE |
| K191088 | Checkme O2 Pulse OximeterDQA · Traditional | Shenzhen Viatom Technology Co., Ltd. | 12/02/2019SE |
| K191430 | Pulse OximeterDQA · Traditional | Shenzhen Yimi Life-Technology Co., Ltd. | 10/18/2019SE |
| K191420 | Reusable SpO2 SensorDQA · Traditional | Shenzhen Changke Connect Electronics Co., Ltd. | 10/11/2019SE |
| K191417 | Belun RingDQA · Traditional | Belun Technology Company Limited | 10/10/2019SE |
| K190869 | Pulse OximeterDQA · Traditional | Shenzhen Aeon Technology Co., Ltd. | 09/13/2019SE |
| K190792 | BB-613WPDQA · Traditional | Biobeat Technologies , Ltd. | 08/22/2019SE |
| K190399 | Beddr 200 SystemDQA · Traditional | Hancock Medical, Inc. | 08/05/2019SE |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemDQA · Special | Taiwan Aulisa Medical Devices Technologies, Inc. | 06/25/2019SE |
| K183277 | SpO2 SensorDQA · Traditional | Shenzhen Upnmed Equipment Co., Ltd. | 05/15/2019SE |
| K181352 | Loop SystemDQA · Traditional | Spry Health, Inc. | 03/29/2019SE |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and AccessoriesDQA · Traditional | Masimo Corporation | 03/22/2019SE |
| K181738 | Medline ReNewal Reprocessed OxiMax Pulse Oximetry SensorsDQA · Traditional | Surgical Instrument Service and Savings Inc (Dba… | 03/22/2019SE |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemDQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 03/01/2019SE |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemDQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 03/01/2019SE |
| K183556 | oCare Wrist Pulse OximeterDQA · Traditional | Taiwan Biophotonic Corporation | 02/15/2019SE |
| K181956 | Masimo MightySat Rx Fingertip Pulse OximeterDQA · Traditional | Masimo Corporation | 01/23/2019SE |
| K180380 | vital signs monitorDQA · Traditional | Edan Instruments, Inc. | 12/21/2018SE |
| K180685 | AS-3XX Series Fingertip Pulse OximeterDQA · Traditional | Xiamen Acurio Instruments Co., Ltd. | 11/29/2018SE |
| K172792 | Handheld Pulse Oximeter, Model SP-20DQA · Traditional | Shenzhen Creative Industry Co., Ltd. | 11/13/2018SE |
| K180046 | Masimo Rad-97 and AccessoriesDQA · Traditional | Masimo Corporation | 10/23/2018SE |
| K181503 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 10/11/2018SE |
| K181006 | BB-613 Watch OximeterDQA · Traditional | Bio-Beat Technologies , Ltd. | 09/21/2018SE |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 SensorsDQA · Traditional | Orantech, Inc. | 09/07/2018SE |
| K173368 | Reusable & Disposable SpO2 SensorsDQA · Traditional | Shenzhen Coreray Technology, Ltd. | 08/31/2018SE |
| K172492 | Optical Topography System ETG-4100DQA · Traditional | Hitachi Healthcare Americas | 08/17/2018SE |
| K173123 | Pulse OximeterDQA · Traditional | Shenzhen Imdk Medical Technology Co., Ltd. | 08/13/2018SE |
| K172616 | Pulse OximeterDQA · Traditional | Beijing Safe Heart Technology , Ltd. | 07/27/2018SE |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 SensorsDQA · Traditional | APK Technology Co., Ltd. | 06/08/2018SE |
| K173045 | OximeterDQA · Traditional | Shenzhen Greatmade Tech Limited | 06/05/2018SE |
| K180174 | Belun RingDQA · Traditional | Belun Technology Company Limited | 05/29/2018SE |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorDQA · Traditional | Nonin Medical, Inc. | 05/11/2018SE |
| K172141 | Pulse OximeterDQA · Traditional | Shanghai Berry Electronic Tech Co., Ltd. | 04/04/2018SE |
| K171241 | Pulse OximeterDQA · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 03/27/2018SE |
| K172366 | Wrist Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 03/16/2018SE |
| K172482 | The Nellcor pulse oximetry monitor interface cableDQA · Traditional | Covidien | 12/15/2017SE |
| K170965 | Fingertip Pulse OximeterDQA · Special | Shenzhen Jumper Medical Equipment Co., Ltd. | 11/03/2017SE |
| K163135 | Finger Pulse OximeterDQA · Traditional | Shenzhen Fitfaith Technology Co.,Ltd | 09/19/2017SE |
| K171423 | Nasal Alar SpO2 SensorDQA · Traditional | Xhale, Inc. | 07/27/2017SE |
| K163382 | Oxitone 1000DQA · Traditional | Oxitone Medical , Ltd. | 05/09/2017SE |
| K161938 | Fingertip Pulse OximeterDQA · Traditional | Xuzhou Yongkang Electronic Science Technology… | 05/08/2017SE |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring SystemDQA · Traditional | Taiwan Aulisa Medical Devices Technologies, Inc. | 03/03/2017SE |
| K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…DQA · Traditional | Bluepoint Medical GmbH & Co. KG | 02/06/2017SE |
| K153184 | Caremed Reusable & Disposable SPO2 SensorsDQA · Traditional | Shenzhen Caremed Medical Technology Co., Ltd. | 01/04/2017SE |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-OximeterDQA · Traditional | Masimo Corporation | 12/28/2016SE |
| K160231 | Model X-100C CO-Met Oximetry SystemDQA · Traditional | Nonin Medical, Inc. | 12/23/2016SE |
| K160940 | Masimo Disposable Transflectance Forehead SensorDQA · Traditional | Masimo Corporation | 11/23/2016SE |
| K153021 | Fingertip Pulse Oximeter A310DQA · Traditional | Amemo, Inc. | 11/22/2016SE |
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51DQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 10/14/2016SE |
| K161560 | Fingertip Pulse Oximeter MD300CN310DQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 10/05/2016SE |
| K160582 | WiCapDQA · Abbreviated | Athena Gtx | 09/02/2016SE |
| K152390 | Medke Oximetry Finger SensorDQA · Traditional | Shenzhen Medke Technology Co., Ltd. | 08/18/2016SE |
| K152091 | Fingertip Pulse OximeterDQA · Traditional | Jiangsu Konsung Bio-Medical Science & Technology… | 08/18/2016SE |
| K152089 | Wrist Pulse OximeterDQA · Traditional | Jiangsu Konsung Bio-Medical Science & Technology… | 08/17/2016SE |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series:…DQA · Traditional | Nonin Medical, Inc. | 08/05/2016SE |
| K152563 | Pulse Oximeter (MD300M/MD300K2)DQA · Traditional | Beijing Choice Electronic Technology Co., Ltd. | 04/18/2016SE |
| K151024 | Finger Type Pulse OximeterDQA · Traditional | Taidoc Technology Corporation | 03/02/2016SE |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DDQA · Traditional | Guangdong Biolight Meditech Co., Ltd. | 01/06/2016SE |
| K150314 | Masimo MightySat Rx Fingertip Pulse OximeterDQA · Traditional | Masimo Corporation | 10/22/2015SE |
| K151206 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 08/28/2015SE |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E…DQA · Special | Shenzhen Creative Industry Co., Ltd. | 06/03/2015SE |
| K141362 | Pulse Oximeter CMS50EWDQA · Traditional | Contec Medical Systems Co.,Ltd | 04/23/2015SE |
| K142687 | Pulse OximeterDQA · Traditional | Shanghai Berry Electronic Tech Co., Ltd. | 04/13/2015SE |
| K142865 | Nellcor Bedside SpO2 Patient Monitoring SystemDQA · Traditional | Covidien, LLC | 03/26/2015SE |
| K142959 | Vyntus WalkDQA · Traditional | Carefusion Germany 234 GmbH | 03/20/2015SE |
| K143216 | Assurance Alar / Nasal SpO2 SensorDQA · Traditional | Xhale, Inc. | 03/17/2015SE |
| K141518 | Nellcor Bedside Respiratory Patient Monitoring SystemDQA · Traditional | Covidien | 03/05/2015SE |
| K142888 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 02/20/2015SE |
| K142832 | Unimed Disposable and Reusable SPO2 SensorsDQA · Traditional | Unimed Medical Supplies, Inc. | 02/06/2015SE |
| K142209 | Pulse oximeter NBM-200DQA · Special | Orsense, Ltd. | 01/16/2015SE |
| K141024 | External Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 01/13/2015SE |
| K141105 | Pulse OximeterDQA · Traditional | Hunan Accurate Bio-Medical Technology Co., Ltd. | 12/04/2014SE |
| K141542 | Nellcor Portable SPO2 Patient Monitoring System ( Npspms )DQA · Traditional | Covidien, LLC | 10/02/2014SE |
| K140582 | Fingertip Pulse OximeterDQA · Traditional | Shenzhen Jumper Medical Equipment Co., Ltd. | 08/28/2014SE |
| K141128 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 08/13/2014SE |
| K132516 | Oxiprobe E (Oxiprobe)DQA · Traditional | Bio Medical Technologies Co., Ltd. | 07/30/2014SE |
| K140682 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 07/17/2014SE |
| K140785 | Pulse OximeterDQA · Traditional | Nonin Medical, Inc. | 07/07/2014SE |
| K133064 | Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…DQA · Traditional | Envitec-Wismar GmbH | 05/02/2014SE |
| K133090 | Oxicare Fingertip Pulse OximeterDQA · Special | Delbio Incorporation | 02/28/2014SE |
| K132402 | Sensmart Model X-100 Univeral Oximetry SystemDQA · Traditional | Nonin Medical, Inc. | 02/21/2014SE |
| K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…DQA · Traditional | Covidien | 02/04/2014SE |
| K124041 | NBM-200MPDQA · Traditional | Orsense, Ltd. | 10/17/2013SE |
| K131047 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 10/16/2013SE |
| K130947 | Fingertip Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 10/03/2013SE |
| K132696 | Trusignal SPO2 Adult and Pediatric Adhesive Wrap Disposable SensorDQA · Special | GE Healthcare Finland Oy | 09/27/2013SE |
| K131111 | Ihealth Fingertip Pulse OximeterDQA · Traditional | Andon Health Co, Ltd. | 09/11/2013SE |
| K131021 | Pulse OximeterDQA · Traditional | Nonin Medical, Inc. | 09/11/2013SE |
| K131818 | Vital Signs MonitorDQA · Special | Edan Instruments, Inc. | 08/30/2013SE |
| K123797 | NT1D Vital Signs MonitorDQA · Traditional | New Tech, Inc. | 08/27/2013SE |
| K123801 | Finger Pulse OximeterDQA · Traditional | Shenzhen Kingyield Technology Co., Ltd. | 05/28/2013SE |
| K123871 | Fingertip Pulse OximeterDQA · Special | Beijing Choice Electronic Technololgy Co., Ltd. | 05/10/2013SE |
| K123581 | Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient Monitoring…DQA · Traditional | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 05/09/2013SE |
| K120984 | Masimo RAS-125C Acoustic Respiration SensorDQA · Traditional | Masimo Corporation | 04/26/2013SE |
| K122996 | Assurance Alar Sensor Model 10078; Ab-N Adapter Cable Model 10085DQA · Traditional | Xhale | 04/10/2013SE |
| K113727 | Shenzhen Med-Link Pulse Oximeter ProbeDQA · Traditional | Shenzhen Med-Link Electronics Tech Co., Ltd. | 03/21/2013SE |
| K122046 | Wrist Pulse OximeterDQA · Traditional | Beijing Choice Electronic Technololgy Co., Ltd. | 02/04/2013SE |
| K122927 | Oxicare Fingertip Pulse OximeterDQA · Traditional | Delbio Incorporated | 12/20/2012SE |
| K120502 | PC-60NW Fingertip OximeterDQA · Abbreviated | Shenzhen Creative Industry Co., Ltd. | 12/07/2012SE |
| K121697 | Fingertip Pulse OximeterDQA · Traditional | Andon Health Co, Ltd. | 10/15/2012SE |
| K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…DQA · Abbreviated | Covidien | 09/28/2012SE |
| K120657 | Masimo Set and Masimo Rainbow Set Pulse Oximeters and SensorsDQA · Traditional | Masimo Corporation | 09/19/2012SE |
| K121914 | Masimo Set USPO2 Pulse Oximetry CableDQA · Special | Masimo Corporation | 09/07/2012SE |
| K120052 | CvinsightDQA · Traditional | Intelomed, Inc. | 09/04/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1153-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | Edan Diagnostics | 10/24/2025Open, Classified |
| Z-1152-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | Edan Diagnostics | 10/24/2025Open, Classified |
| Z-1143-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | Edan Diagnostics | 10/24/2025Open, Classified |
| Z-1142-2026 Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product…As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential… | Edan Diagnostics | 10/24/2025Open, Classified |
| Z-2151-2025 Class II | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941…Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of… | Covidien | 06/23/2025Open, Classified |
| Z-0279-2025 Class II | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated…Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may… | Accriva Diagnostics, Inc. | 09/27/2024Completed |
| Z-0268-2025 Class II | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear…Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Nihon Kohden America Inc | 09/18/2024Open, Classified |
| Z-0267-2025 Class II | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp.…Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | Nihon Kohden America Inc | 09/18/2024Open, Classified |
| Z-3099-2024 Class II | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW…This product labeling does not adequately provide warning about the risks associated with the use of damaged… | Zoe Medical Incorporated | 08/13/2024Open, Classified |
| Z-3098-2024 Class II | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model…This product labeling does not adequately provide warning about the risks associated with the use of damaged… | Zoe Medical Incorporated | 08/13/2024Open, Classified |
| Z-1539-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Masimo Corporation | 02/15/2024Open, Classified |
| Z-1538-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Masimo Corporation | 02/15/2024Open, Classified |
| Z-1537-2024 Class II | Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Masimo Corporation | 02/15/2024Open, Classified |
| Z-1536-2024 Class II | Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. | Masimo Corporation | 02/15/2024Open, Classified |
| Z-1986-2023 Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503TC-I tip clip sensor may produce readings outside the accuracy specification. | Masimo Corporation | 04/21/2023Open, Classified |
| Z-1985-2023 Class II | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895TC-I tip clip sensor may produce readings outside the accuracy specification. | Masimo Corporation | 04/21/2023Open, Classified |
| Z-1984-2023 Class II | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794TC-I tip clip sensor may produce readings outside the accuracy specification. | Masimo Corporation | 04/21/2023Open, Classified |
| Z-1983-2023 Class II | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053TC-I tip clip sensor may produce readings outside the accuracy specification. | Masimo Corporation | 04/21/2023Open, Classified |
| Z-1360-2026 Class III | Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | Surepulse Medical Ltd | 01/20/2023Open, Classified |
| Z-1359-2026 Class III | Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | Surepulse Medical Ltd | 01/20/2023Open, Classified |
| Z-1358-2026 Class III | Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | Surepulse Medical Ltd | 01/20/2023Open, Classified |
| Z-1357-2026 Class III | Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | Surepulse Medical Ltd | 01/20/2023Open, Classified |
| Z-1356-2026 Class III | Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate MonitorRetroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate… | Surepulse Medical Ltd | 01/20/2023Open, Classified |
| Z-2133-2019 Class II | Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The…These Instructions for Use has missing instructions related to the checking and changing of the application… | Xhale Assurance, Inc. | 05/08/2019Terminated |
| Z-0056-2019 Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0055-2019 Class II | CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COVThe date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0054-2019 Class II | Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0053-2019 Class II | Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0052-2019 Class II | Capnostream20 (INTL) M REFURBISHED, CS78654The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0051-2019 Class II | Capnostream20 (INTL) N REFURBISHED, CS78652The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0050-2019 Class II | Capnostream20 N CYVITAL, CS08799The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0049-2019 Class II | Capnostream20 N W/PRINTER CYVITAL, CS08798The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0048-2019 Class II | Capnostream20 M W/PRINTER CYVITAL, CS08796The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0047-2019 Class II | Capnostream20 (INTL) M W/PRINTER, CS08660The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0046-2019 Class II | Capnostream20 M NICU (CPM), CS08654RNThe date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0045-2019 Class II | Capnostream20 M ADULT ICU (CPM), CS08654RAThe date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0044-2019 Class II | Capnostream20 (INTL) M, CS08654The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0043-2019 Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0042-2019 Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0041-2019 Class II | CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0040-2019 Class II | CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0039-2019 Class II | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0038-2019 Class II | CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-02The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0037-2019 Class II | CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0036-2019 Class II | CAPNOSTREAM 20 (INTL) N, Part Number CS08652The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0035-2019 Class II | Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0034-2019 Class II | Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0033-2019 Class II | Capnostream20 (US)M REFURBISHED, Part Number CS78653The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0032-2019 Class II | Capnostream20 (US) N REFURBISHED, Part Number CS78651The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |
| Z-0031-2019 Class II | Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory… | Oridion Medical 1987 Ltd. | 07/31/2018Terminated |