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) → MUD — Oximeter, Tissue Saturation # MUD · Oximeter, Tissue Saturation _Cardiovascular · 21 CFR 870.2700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD ## Overview - **Product Code:** MUD - **Device Name:** Oximeter, Tissue Saturation - **Regulation:** [21 CFR 870.2700](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2700) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## 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 73) Showing 20 most recent of 73 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243324](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K243324.md) | Masimo O3 Regional Oximeter | Masimo Corporation | Jul 17, 2025 | SESE | | [K250519](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K250519.md) | Lap.Ox™ Laparoscopic Tissue Oximeter | ViOptix, Inc. | Jun 26, 2025 | SESE | | [K240596](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K240596.md) | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | Oct 16, 2024 | SESE | | [K241393](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K241393.md) | ODI-Tech | Odi Medical AS | Aug 30, 2024 | SESE | | [K240601](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K240601.md) | SnapshotNIR model KD205 | Kent Imaging, Inc. | Apr 2, 2024 | SESE | | [K232385](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K232385.md) | OxiplexTS200 | Iss Medical, Inc. | Mar 1, 2024 | SESE | | [K233488](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K233488.md) | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | Feb 28, 2024 | SESE | | [K230612](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K230612.md) | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | Nov 17, 2023 | SESE | | [K223651](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K223651.md) | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | May 26, 2023 | SESE | | [K214072](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K214072.md) | Masimo O3 Regional Oximeter System | Masimo Corporation | May 6, 2022 | SESE | | [K221010](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K221010.md) | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | May 3, 2022 | SESE | | [K211561](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K211561.md) | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | Covidien, LLC | Dec 5, 2021 | SESE | | [K203490](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K203490.md) | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | Feb 10, 2021 | SESE | | [K201976](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K201976.md) | SnapshotNIR | Kent Imaging | Nov 10, 2020 | SESE | | [K201432](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K201432.md) | Masimo O3 Regional Oximeter System | Masimo Corporation | Aug 29, 2020 | SESE | | [K190334](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K190334.md) | MIMOSA Imager | Mimosa Diagnostics, Inc. | Nov 1, 2019 | SESE | | [K190270](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K190270.md) | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | Oct 21, 2019 | SESE | | [K192322](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K192322.md) | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | Sep 23, 2019 | SESE | | [K191676](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K191676.md) | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | Sep 16, 2019 | SESE | | [K182429](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD/K182429.md) | Masimo O3 Regional Oximeter System | Masimo Corporation | Jun 7, 2019 | SESE | ## Top Applicants - Cas Medical Systems, Inc. — 9 clearances - Hutchinson Technology, Inc. — 8 clearances - Vioptix, Inc. — 7 clearances - Masimo Corporation — 6 clearances - Nonin Medical, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MUD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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