MUD — Oximeter, Tissue Saturation Class II
FDA product code MUD covers "Oximeter, Tissue Saturation", a Class II medical device regulated under 21 CFR 870.2700. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUD
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254129 | neko health | Spectrum-2 | May 22, 2026 |
| K243324 | masimo corporation | Masimo O3 Regional Oximeter | July 17, 2025 |
| K250519 | vioptix | Lap.Ox Laparoscopic Tissue Oximeter | June 26, 2025 |
| K240596 | edwards lifesciences | Cerebral Autoregulation Index (CAI) Algorithm | October 16, 2024 |
| K241393 | odi medical | ODI-Tech | August 30, 2024 |
| K240601 | kent imaging | SnapshotNIR model KD205 | April 2, 2024 |
| K232385 | iss medical | OxiplexTS200 | March 1, 2024 |
| K233488 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | February 28, 2024 |
| K230612 | edwards lifesciences | Edwards Algorithm for Measurement of Blood Hemoglobin | November 17, 2023 |
| K223651 | edwards lifesciences | Cerebral Adaptive Index (CAI) Algorithm | May 26, 2023 |
| K214072 | masimo corporation | Masimo O3 Regional Oximeter System | May 6, 2022 |
| K221010 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | May 3, 2022 |
| K211561 | covidien | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional | December 5, 2021 |
| K203490 | edwards lifesciences | FORE-SIGHT ELITE Absolute Tissue Oximeter | February 10, 2021 |
| K201976 | kent imaging | SnapshotNIR | November 10, 2020 |
| K201432 | masimo corporation | Masimo O3 Regional Oximeter System | August 29, 2020 |
| K190334 | mimosa diagnostics | MIMOSA Imager | November 1, 2019 |
| K190270 | cas medical systems | FORE-SIGHT ELITE Tissue Oximeter Module | October 21, 2019 |
| K192322 | spectros corporation | T-Stat 2.0 Microvascular Tissue Oximeter | September 23, 2019 |
| K191676 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | September 16, 2019 |