MUD
- Product code
- MUD
- Device name
- Oximeter, Tissue Saturation
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2700
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 74 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254129 | 2026-05-22 | Neko Health AB | Spectrum-2 | |
| K243324 | 2025-07-17 | Masimo Corporation | Masimo O3 Regional Oximeter | |
| K250519 | 2025-06-26 | ViOptix, Inc. | Lap.Ox Laparoscopic Tissue Oximeter | |
| K240596 | 2024-10-16 | Edwards Lifesciences | Cerebral Autoregulation Index (CAI) Algorithm | |
| K241393 | 2024-08-30 | Odi Medical AS | ODI-Tech | — |
| K240601 | 2024-04-02 | Kent Imaging, Inc. | SnapshotNIR model KD205 | |
| K232385 | 2024-03-01 | Iss Medical, Inc. | OxiplexTS200 | FDA |
| K233488 | 2024-02-28 | Vioptix, Inc. | Intra.Ox 2.0 Handheld Tissue Oximeter | |
| K230612 | 2023-11-17 | Edwards Lifesciences, LLC | Edwards Algorithm for Measurement of Blood Hemoglobi |
Official FDA classification page: MUD
Classification and pathway per current FDA publications. Data from openFDA (CC0).