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Oximeter
FDA product code DQA · Class 2 · Cardiovascular
9,929
Registered devices
14,142
Adverse events
128
Recalls
727
510(k) clearances
Devices with this code
TC sensor, Fixation kit — Radiometer Medical ApSUnimed — Unimed Medical Supplies, Inc.SpO2.COM® NRC-180 Patient Cable — MASIMO CORPORATIONMasimoSET® M-LNCS™ TF-I SpO2 Adult Reusable Forehead Sensor — MASIMO CORPORATIONLutech — LUTECH INDUSTRIES INCUnimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.PORTRAIT SpO2 P-SA01 — GE Healthcare Finland OyExhalation Valve — Respironics, Inc.Unimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.Vive Precision — VIVE HEALTH LLCUnimed — Unimed Medical Supplies, Inc.Unimed — Unimed Medical Supplies, Inc.APK — APK Technology Co.,Ltd.APK — APK Technology Co.,Ltd.APK — APK Technology Co.,Ltd.APK — APK Technology Co.,Ltd.JUMPER — Shenzhen Jumper Medical Equipment Co.,Ltd.HoMedics — HOMEDICS USA, LLCUnimed — Unimed Medical Supplies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-06-23 | Covidien | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, |
| 2024-09-27 | Accriva Diagnostics, Inc. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen lev |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-09-18 | Nihon Kohden America Inc | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
| 2024-08-13 | Zoe Medical Incorporated | This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life. |
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