FDA Product Code
FDA Product Code DQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 727 records · page 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260490 | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) | Shenzhen Ninenovo Technology Limited | 2026-10-02 | Traditional | PDF ↗ |
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T) | Philips Medizin Systeme Böblingen GmbH | 2026-05-29 | Traditional | PDF ↗ |
| K252655 | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-05-11 | Traditional | PDF ↗ |
| K253887 | Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) | Philips Medizin Systeme | 2026-05-01 | Traditional | PDF ↗ |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026-04-14 | Special | PDF ↗ |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | 2026-02-27 | Traditional | PDF ↗ |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 | Traditional | PDF ↗ |
| K253109 | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | 2026-01-07 | Traditional | PDF ↗ |
| K251751 | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | 2025-12-19 | Traditional | PDF ↗ |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29) | Unimed Medical Supplies, Inc. | 2025-12-01 | Traditional | PDF ↗ |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08) | Unimed Medical Supplies, Inc. | 2025-12-01 | Traditional | PDF ↗ |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75) | Unimed Medical Supplies, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06) | Unimed Medical Supplies, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K250837 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2025-09-25 | Traditional | PDF ↗ |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies, Inc. | 2025-08-13 | Traditional | PDF ↗ |
| K241086 | Avidhrt Sense SpO2 | Avidhrt, Inc. | 2025-05-09 | Traditional | PDF ↗ |
| K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025-02-28 | Traditional | PDF ↗ |
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-02-25 | Traditional | PDF ↗ |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91) | Unimed Medical Supplies, Inc. | 2025-02-20 | Traditional | PDF ↗ |
| K242455 | AViTA Pulse Oximeter (SP62B) | Avita Corporation | 2025-02-19 | Traditional | PDF ↗ |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) | Unimed Medical Supplies, Inc. | 2025-02-06 | Traditional | PDF ↗ |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2025-01-30 | Traditional | PDF ↗ |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2025-01-02 | Traditional | PDF ↗ |
| K241090 | Evie Med Ring | Movano Inc. Dba Movano Health | 2024-11-29 | Traditional | PDF ↗ |
| K232520 | Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH | Shenzhen Smallsignal Technology Co., Ltd. | 2024-11-21 | Traditional | PDF ↗ |
| K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | Shenzhen Yimi Life Technology Co., Ltd. | 2024-10-25 | Traditional | PDF ↗ |
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | 2024-10-11 | Traditional | PDF ↗ |
| K240808 | Pulse Oximeter (WS20A) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2024-10-03 | Traditional | PDF ↗ |
| K233827 | OxiWear | Oxiwear, Inc. | 2024-08-28 | Traditional | PDF ↗ |
| K231979 | Mecun SpO2 sensor | Shenzhen Mecun Medical Supply Co., Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | Shenzhen AOJ Medical Technology Co., Ltd. | 2024-07-01 | Traditional | PDF ↗ |
| K232975 | Pulse Oximeter (MD300C228) | Beijing Choice Electronic Technology Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K240305 | ANNE Limb | Sibel Health, Inc. | 2024-05-28 | Traditional | PDF ↗ |
| K223399 | AViTA Pulse Oximeter | Avita Corporation | 2024-05-20 | Traditional | PDF ↗ |
| K232495 | Sempulse Halo Vital Signs Monitor | Sempulse Corporation | 2024-05-16 | Traditional | PDF ↗ |
| K231288 | Vyvo | Vyvo Technology Corp.(Vt) | 2024-03-04 | Traditional | PDF ↗ |
| K230277 | Pulse Oximeter(Model OHT60,OXH78) | Cofoe Medical Technology Co., Ltd. | 2024-01-04 | Traditional | PDF ↗ |
| K231531 | Pediarity | Hinlab, Inc. | 2023-12-21 | Traditional | PDF ↗ |
| K223721 | Masimo Stork | Masimo Corporation | 2023-12-15 | Traditional | PDF ↗ |
| K230587 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-11-30 | Traditional | PDF ↗ |
| K231243 | Finger Clip Pulse Oximeter | Guangdong Genial Technology Co., Ltd. | 2023-10-31 | Traditional | PDF ↗ |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | 2023-09-07 | Special | PDF ↗ |
| K221361 | circul pro Ring | Bodimetrics, LLC | 2023-08-29 | Traditional | PDF ↗ |
| K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-08-12 | Traditional | PDF ↗ |
| K211143 | Pulse Oximeter | Shenzhen Brav Electronic Technologies Co., Ltd. | 2023-07-17 | Traditional | PDF ↗ |
| K222597 | BabySat 3 | Owlet Babycare, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K221798 | Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. | 2023-05-04 | Traditional | PDF ↗ |
| K213676 | Masimo Rad-G with Temperature | Masimo Corporation | 2023-04-16 | Traditional | PDF ↗ |
| K220101 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2023-03-08 | Traditional | PDF ↗ |
| K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023-02-26 | Traditional | PDF ↗ |
| K213430 | Fingertip Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2022-12-30 | Traditional | PDF ↗ |
| K222010 | Biobeat Platform-2 and BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-12-30 | Traditional | PDF ↗ |
| K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) | Unimed Medical Supplies, Inc. | 2022-12-19 | Traditional | PDF ↗ |
| K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | Shenzhen Zhengkang Technology Co., Ltd. | 2022-12-16 | Traditional | PDF ↗ |
| K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022-11-20 | Traditional | PDF ↗ |
| K220351 | Polso Watch | Chronisense Medical, Ltd. | 2022-11-18 | Traditional | PDF ↗ |
| K203812 | Oxyfit Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2022-11-08 | Traditional | PDF ↗ |
| K221979 | Pulse Oximeter (Model C101A2, C101B1, C101A3) | Shenzhen Imdk Medical Technology Co., Ltd. | 2022-10-16 | Special | PDF ↗ |
| K212385 | YUWELL Finger Pulse Oximeter | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-08-16 | Traditional | PDF ↗ |
| K221953 | Masimo CARESCAPE SpO2 Masimo with SpHb | Masimo Corporation | 2022-08-04 | Special | PDF ↗ |
| K212665 | Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) | Huizhou Xiaoou Technology Co., Ltd. | 2022-06-22 | Traditional | PDF ↗ |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022-06-12 | Traditional | PDF ↗ |
| K213515 | WesperO2 | Wesper, Inc. | 2022-06-10 | Traditional | PDF ↗ |
| K212752 | Med-link Pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2022-05-20 | Traditional | PDF ↗ |
| K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC | Covidien, LLC | 2022-05-06 | Traditional | PDF ↗ |
| K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies , Ltd. | 2022-03-25 | Traditional | PDF ↗ |
| K211140 | Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 | Stryker Sustainability Solutions | 2022-03-08 | Traditional | PDF ↗ |
| K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | 2022-02-25 | Traditional | PDF ↗ |
| K211400 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K211632 | Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) | Shenzhen Narig Bio-Medical Technology Co., Ltd. | 2022-01-14 | Traditional | PDF ↗ |
| K210305 | Pulse Oximeter | Dongguan Lingxin Technologies Co., Ltd. | 2021-12-22 | Traditional | PDF ↗ |
| K211407 | Belun Ring BLR-100X | Belun Technology Company Limited | 2021-10-21 | Traditional | PDF ↗ |
| K212876 | Carescape SpO2 - Masimo | Masimo Corporation | 2021-10-08 | Special | PDF ↗ |
| K210032 | Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) | Leadtek Research, Inc. | 2021-09-01 | Special | PDF ↗ |
| K210274 | Fingertip Pulse Oximeter | Zhuhai Linte Medical Instrument Co., Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K201887 | VS Newborn Heart Rate Monitor | Surepulse Medical Limited | 2021-07-23 | Traditional | PDF ↗ |
| K203854 | Pulse Oximeter | Shenzhen Hexin Zondan Medical Equipment Co., Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K202776 | Fingertip pulse oximeter | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-03-01 | Traditional | PDF ↗ |
| K202743 | Med-Link Temp-pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-03-01 | Traditional | PDF ↗ |
| K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021-01-25 | Traditional | PDF ↗ |
| K202324 | Fingertip Pulse Oximeter | Shenzhen Bsx Technology Electronics Co., Ltd. | 2020-12-14 | Traditional | PDF ↗ |
| K201384 | Pulse Oximeter | Shenzhen Raysintone Technology Co., Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K202173 | Pulse Oximeter | Shenzhen AOJ Medical Technology Co., Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K201294 | Pulse Oximeter | Guangdong Long Yao Electronic Technology Co., Ltd. | 2020-11-27 | Traditional | PDF ↗ |
| K202851 | Spo2 Sensor | Jkh USA, LLC | 2020-11-27 | Traditional | PDF ↗ |
| K201770 | Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor | Masimo Corporation | 2020-09-24 | Special | PDF ↗ |
| K200414 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | 2020-09-23 | Traditional | PDF ↗ |
| K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co. , Ltd. | 2020-08-19 | Traditional | PDF ↗ |
| K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Covidien, LLC | 2020-07-20 | Traditional | PDF ↗ |
| K200537 | Oxxiom | True Wearables, Inc. | 2020-07-03 | Traditional | PDF ↗ |
| K192900 | H500 Multi-Sensing Oximetry System | Nonin Medical, Inc. | 2020-06-29 | Traditional | PDF ↗ |
| K193350 | Leadtek Fingertip Pulse Oximeter | Leadtek Research, Inc. | 2020-04-27 | Traditional | PDF ↗ |
| K191574 | OxSAT 100 | S.L.P. , Ltd. | 2020-04-09 | Traditional | PDF ↗ |
| K200069 | Disposable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2020-03-13 | Traditional | PDF ↗ |
| K192608 | Disposable SpO2 Sensor | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020-01-24 | Traditional | PDF ↗ |
| K192343 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2019-12-31 | Traditional | PDF ↗ |
| K191403 | Pulse Oximeter | Nonin Medical, Inc. | 2019-12-20 | Traditional | PDF ↗ |
| K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | 2019-12-06 | Traditional | PDF ↗ |
| K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019-12-02 | Traditional | PDF ↗ |
| K191430 | Pulse Oximeter | Shenzhen Yimi Life-Technology Co., Ltd. | 2019-10-18 | Traditional | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.