MUD · Oximeter, Tissue Saturation
Cardiovascular · 21 CFR 870.2700 · Class 2
Overview
| Product Code | MUD |
|---|---|
| Device Name | Oximeter, Tissue Saturation |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Masimo O3 Regional Oximeter | Masimo Corporation | Jul 17, 2025 | SESE |
| K250519 | Lap.Ox Laparoscopic Tissue Oximeter | ViOptix, Inc. | Jun 26, 2025 | SESE |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | Oct 16, 2024 | SESE |
| K241393 | ODI-Tech | Odi Medical AS | Aug 30, 2024 | SESE |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | Apr 2, 2024 | SESE |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | Mar 1, 2024 | SESE |
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | Feb 28, 2024 | SESE |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | Nov 17, 2023 | SESE |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | May 26, 2023 | SESE |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | May 6, 2022 | SESE |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | May 3, 2022 | SESE |
| K211561 | 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 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | Feb 10, 2021 | SESE |
| K201976 | SnapshotNIR | Kent Imaging | Nov 10, 2020 | SESE |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | Aug 29, 2020 | SESE |
| K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | Nov 1, 2019 | SESE |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | Oct 21, 2019 | SESE |
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | Sep 23, 2019 | SESE |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | Sep 16, 2019 | SESE |
| K182429 | 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
