Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) → DQA — Oximeter # DQA · Oximeter _Cardiovascular · 21 CFR 870.2700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA ## Overview - **Product Code:** DQA - **Device Name:** Oximeter - **Regulation:** [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 723) Showing 20 most recent of 723 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260931](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K260931.md) | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | Apr 14, 2026 | SESE | | [K252448](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K252448.md) | AViTA Pulse Oximeter (SP61) | Avita Corporation | Feb 27, 2026 | SESE | | [K252805](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K252805.md) | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Feb 17, 2026 | SESE | | [K253109](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K253109.md) | Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) | Shenzhen Best Electronics Co., Ltd. | Jan 7, 2026 | SESE | | [K251751](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K251751.md) | Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. | Dec 19, 2025 | SESE | | [K251696](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K251696.md) | 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. | Dec 1, 2025 | SESE | | [K251691](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K251691.md) | 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. | Dec 1, 2025 | SESE | | [K251695](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K251695.md) | 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. | Nov 18, 2025 | SESE | | [K251693](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K251693.md) | 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. | Nov 18, 2025 | SESE | | [K250837](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K250837.md) | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | Sep 25, 2025 | SESE | | [K250931](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K250931.md) | 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. | Aug 13, 2025 | SESE | | [K241086](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K241086.md) | Avidhrt Sense SpO2 | Avidhrt, Inc. | May 9, 2025 | SESE | | [K242876](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K242876.md) | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | Feb 28, 2025 | SESE | | [K233963](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K233963.md) | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) | Taiwan Aulisa Medical Devices Technologies, Inc. | Feb 25, 2025 | SESE | | [K243086](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K243086.md) | 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. | Feb 20, 2025 | SESE | | [K242455](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K242455.md) | AViTA Pulse Oximeter (SP62B) | Avita Corporation | Feb 19, 2025 | SESE | | [K242580](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K242580.md) | 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. | Feb 6, 2025 | SESE | | [K233956](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K233956.md) | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) | Taiwan Aulisa Medical Devices Technologies, Inc. | Jan 30, 2025 | SESE | | [K243049](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K243049.md) | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | Jan 2, 2025 | SESE | | [K241090](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K241090.md) | Evie Med Ring | Movano Inc. Dba Movano Health | Nov 29, 2024 | SESE | ## Top Applicants - Masimo Corporation — 49 clearances - Nonin Medical, Inc. — 42 clearances - Masimo Corp. — 28 clearances - Beijing Choice Electronic Technololgy Co., Ltd. — 21 clearances - Nellcor Puritan Bennett, Inc. — 19 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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