ClearanceBrief
Panels › Cardiovascular › Product code DQA · Class 2

Oximeter

Regulation 870.2700

13510(k)s in 12 months (727 all time)
9recalls in 12 months (128 all time)
101recalls that name a 510(k)
Get daily alerts for DQASample briefCSV

Top companies in DQA

Company510(k)sRecalls
Masimo Corp.7714
Nonin Medical, Inc.423
Oridion Medical 1987 , Ltd.132
Philips Healthcare Inc.025
Nellcor Puritan Bennett, Inc.194
Beijing Choice Electronic Technololgy Co., Ltd.210
Philips Medical Systems85
Covidien102
Dolphin Medical, Inc.120
Bci Intl., Inc.110
Decided510(k)Device and applicantCode
Oct 2, 2026K260490Ninenovo 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,
Shenzhen Ninenovo Technology Limited, CN
DQA
May 29, 2026K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)
Philips Medizin Systeme Böblingen GmbH, DE
DQA
May 11, 2026K252655Pulse 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., CN
DQA
May 1, 2026K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
Philips Medizin Systeme, DE
DQA
Apr 14, 2026K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
Unimed Medical Supplies, Inc., CN
DQA
Feb 27, 2026K252448AViTA Pulse Oximeter (SP61)
Avita Corporation, CN
DQA
Feb 17, 2026K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
DQA
Jan 7, 2026K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
Shenzhen Best Electronics Co., Ltd., CN
DQA
Dec 19, 2025K251751Spo2 Sensor CSS032D
Shenzhen Ykd Technology Co., Ltd., CN
DQA
Dec 1, 2025K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Ser
Unimed Medical Supplies, Inc., CN
DQA
Dec 1, 2025K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusa
Unimed Medical Supplies, Inc., CN
DQA
Nov 18, 2025K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusa
Unimed Medical Supplies, Inc., CN
DQA
Nov 18, 2025K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusabl
Unimed Medical Supplies, Inc., CN
DQA
Sep 25, 2025K250837Pulse Oximeter
Shanghai Berry Electronic Tech Co., Ltd., CN
DQA
Aug 13, 2025K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U10
Unimed Medical Supplies, Inc., CN
DQA
May 9, 2025K241086Avidhrt Sense SpO2
Avidhrt, Inc.
DQA
Feb 28, 2025K242876Pulse Oximeter ( PO2, PO2A, PO2B)
Shenzhen Viatom Technology Co., Ltd., CN
DQA
Feb 25, 2025K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
Taiwan Aulisa Medical Devices Technologies, Inc., TW
DQA
Feb 20, 2025K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 S
Unimed Medical Supplies, Inc., CN
DQA
Feb 19, 2025K242455AViTA Pulse Oximeter (SP62B)
Avita Corporation, TW
DQA
Feb 6, 2025K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusabl
Unimed Medical Supplies, Inc., CN
DQA
Jan 30, 2025K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
Taiwan Aulisa Medical Devices Technologies, Inc., TW
DQA
Jan 2, 2025K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
Hunan Accurate Bio-Medical Technology Co., Ltd., CN
DQA
Nov 29, 2024K241090Evie Med Ring
Movano Inc. Dba Movano Health
DQA
Nov 21, 2024K232520Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20
Shenzhen Smallsignal Technology Co., Ltd., CN
DQA
Oct 25, 2024K240092Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314,
Shenzhen Yimi Life Technology Co., Ltd., CN
DQA
Oct 11, 2024K234110Belun Ring BLR-200 (BLR-200)
Belun Technology Company Limited, HK
DQA
Oct 3, 2024K240808Pulse Oximeter (WS20A)
Hunan Accurate Bio-Medical Technology Co., Ltd., CN
DQA
Aug 28, 2024K233827OxiWear
Oxiwear, Inc.
DQA
Aug 16, 2024K231979Mecun SpO2 sensor
Shenzhen Mecun Medical Supply Co., Ltd., CN
DQA
Jul 1, 2024K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (
Shenzhen AOJ Medical Technology Co., Ltd., CN
DQA
Jun 21, 2024K232975Pulse Oximeter (MD300C228)
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
May 28, 2024K240305ANNE Limb
Sibel Health, Inc.
DQA
May 20, 2024K223399AViTA Pulse Oximeter
Avita Corporation, TW
DQA
May 16, 2024K232495Sempulse Halo Vital Signs Monitor
Sempulse Corporation
DQA
Mar 4, 2024K231288Vyvo
Vyvo Technology Corp.(Vt)
DQA
Jan 4, 2024K230277Pulse Oximeter(Model OHT60,OXH78)
Cofoe Medical Technology Co., Ltd., CN
DQA
Dec 21, 2023K231531Pediarity™
Hinlab, Inc.
DQA
Dec 15, 2023K223721Masimo Stork
Masimo Corporation
DQA
Nov 30, 2023K230587Wrist Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
Oct 31, 2023K231243Finger Clip Pulse Oximeter
Guangdong Genial Technology Co., Ltd., CN
DQA
Sep 7, 2023K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
Masimo Corporation
DQA
Aug 29, 2023K221361circul™ pro Ring
Bodimetrics, LLC
DQA
Aug 12, 2023K230172Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
Jul 17, 2023K211143Pulse Oximeter
Shenzhen Brav Electronic Technologies Co., Ltd., CN
DQA
Jun 16, 2023K222597BabySat 3
Owlet Babycare, Inc.
DQA
May 4, 2023K221798Finger Pulse Oximeter, Model: X1906P
Shenzhen Changkun Technology Co., Ltd., CN
DQA
Apr 16, 2023K213676Masimo Rad-G with Temperature
Masimo Corporation
DQA
Mar 8, 2023K220101Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd., CN
DQA
Feb 26, 2023K213431Handheld Pulse Oximeter
Shenzhen Witleaf Medical Electronics Co., Ltd., CN
DQA

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.