Product code MUD
- Device name
- Oximeter, Tissue Saturation
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2700
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254129 | Spectrum-2 | Neko Health AB | 2026-05-22 |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025-07-17 |
| K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | ViOptix, Inc. | 2025-06-26 |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024-10-16 |
| K241393 | ODI-Tech | Odi Medical AS | 2024-08-30 |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | 2024-04-02 |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024-03-01 |
| K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024-02-28 |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023-11-17 |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023-05-26 |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022-05-06 |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022-05-03 |
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | Covidien, LLC | 2021-12-05 |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021-02-10 |
| K201976 | SnapshotNIR | Kent Imaging | 2020-11-10 |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020-08-29 |
| K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | 2019-11-01 |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019-10-21 |
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019-09-23 |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019-09-16 |
| K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019-06-07 |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | Nonin Medical, Inc. | 2019-05-02 |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | Covidien, LLC | 2019-01-08 |
| K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | 2018-08-09 |
| K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018-07-19 |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018-05-10 |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017-11-16 |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017-05-26 |
| K163070 | Kent Camera | Kent Imaging, Inc. | 2017-05-05 |
| K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016-12-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521701243 | INVOS | Covidien LP | 2024-04-14 |
| 10884521807433 | INVOS | Covidien LP | 2021-06-19 |
| 10884521810105 | INVOS | Covidien LP | 2021-06-14 |
| 10843997013496 | O3 | MASIMO CORPORATION | 2020-09-03 |
| 10884521780118 | INVOS | Covidien LP | 2019-07-30 |
| 10884521552616 | INVOS | Covidien LP | 2019-06-12 |
| 10884521556959 | INVOS | Covidien LP | 2019-03-10 |
| 10609538610001 | FORE-SIGHT ELITE | CAS MEDICAL SYSTEMS, INC. | 2018-12-12 |
| 10609538610018 | FORE-SIGHT ELITE | CAS MEDICAL SYSTEMS, INC. | 2018-12-12 |
| 10609538611008 | FORE-SIGHT ELITE | CAS MEDICAL SYSTEMS, INC. | 2018-12-12 |
| 10609538741033 | FORE-SIGHT ELITE | CAS MEDICAL SYSTEMS, INC. | 2018-12-12 |
| 10843997008416 | 03 Sensor rS02 Large Adhesive Sensor | MASIMO CORPORATION | 2017-10-12 |
| 10609538710077 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538711036 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538711029 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538711012 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538711005 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538600057 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710060 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710053 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710046 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710039 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710022 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538710008 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538631013 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538631006 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538630146 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538630009 | FORE-SIGHT ELITE® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10609538600439 | FORE-SIGHT® | CAS MEDICAL SYSTEMS, INC. | 2017-03-06 |
| 10884521211162 | INVOS | Covidien LP | 2016-09-24 |