Oximeter, Tissue Saturation
FDA product code MUD · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular
74510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Cas Medical Systems, Inc. 9
- Vioptix, Inc. 8
- Hutchinson Technology, Inc. 8
- Masimo Corporation 6
- Nonin Medical, Inc. 5
- Reflectance Medical, Inc. 5
- Edwards Lifesciences, LLC 4
- Somanetics Corp. 4
- Kent Imaging, Inc. 4
- Spectros Corporation 3
- Or-Nim Medical , Ltd. 3
- Hamamatsu Photonics K.K. 2
- Hypermed, Inc. 2
- Modulated Imaging, Inc. 2
- Covidien LLC 2
- Iss Medical, Inc. 1
- Neko Health AB 1
- Mimosa Diagnostics, Inc. 1
- Christie Medical Holdings, Inc. 1
- Hypermed Imaging, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | Masimo Corporation | 07/17/2025SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
| K214072 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 05/06/2022SE |
| K221010 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Special | Vioptix, Inc. | 05/03/2022SE |
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional…MUD · Traditional | Covidien, LLC | 12/05/2021SE |
| K203490 | FORE-SIGHT ELITE Absolute Tissue OximeterMUD · Traditional | Edwards Lifesciences, LLC | 02/10/2021SE |
| K201976 | SnapshotNIRMUD · Traditional | Kent Imaging | 11/10/2020SE |
| K201432 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 08/29/2020SE |
| K190334 | MIMOSA ImagerMUD · Traditional | Mimosa Diagnostics, Inc. | 11/01/2019SE |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter ModuleMUD · Traditional | Cas Medical Systems, Inc. | 10/21/2019SE |
| K192322 | T-Stat 2.0 Microvascular Tissue OximeterMUD · Special | Spectros Corporation | 09/23/2019SE |
| K191676 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 09/16/2019SE |
| K182429 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 06/07/2019SE |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI…MUD · Traditional | Nonin Medical, Inc. | 05/02/2019SE |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorMUD · Traditional | Covidien, LLC | 01/08/2019SE |
| K171245 | Presygen/si-1MUD · Traditional | Christie Medical Holdings, Inc. | 08/09/2018SE |
| K181623 | Clarifi Imaging SystemMUD · Special | Modulated Imaging, Inc. | 07/19/2018SE |
| K180003 | FORE-SIGHT ELITE Module Tissue OximeterMUD · Traditional | Cas Medical Systems, Inc. | 05/10/2018SE |
| K163472 | Intra.Ox Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 11/16/2017SE |
| K162603 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 05/26/2017SE |
| K163070 | Kent CameraMUD · Traditional | Kent Imaging, Inc. | 05/05/2017SE |
| K153426 | Ox-Imager CSMUD · Traditional | Modulated Imaging, Inc. | 12/21/2016SE |
| K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement SystemMUD · Traditional | Hypermed Imaging, Inc. | 12/16/2016SE |
| K162117 | NIRO-200NX DPMUD · Traditional | Hamamatsu Photonics K.K. | 10/25/2016SE |
| K160526 | Masimo O3 Regional Oximeter SystemMUD · Traditional | Masimo Corporation | 06/09/2016SE |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model…MUD · Traditional | Nonin Medical, Inc. | 08/27/2015SE |
| K143219 | NIRO-200NXMUD · Traditional | Hamamatsu Photonics K.K. | 07/31/2015SE |
| K143675 | FORE-SIGHT Elite Absolute Tissue OximeterMUD · Traditional | Cas Medical Systems, Inc. | 04/10/2015SE |
| K133983 | Intra. Ox Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 09/12/2014SE |
| K141496 | Multi-Parameter Mobile Careguide 4100 OximeterMUD · Traditional | Reflectance Medical, Inc. | 08/04/2014SE |
| K141234 | Odissey Tissue OximeterMUD · Traditional | Vioptix, Inc. | 07/01/2014SE |
| K133879 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | Cas Medical Systems, Inc. | 04/29/2014SE |
| K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with TabletMUD · Traditional | Reflectance Medical, Inc. | 04/11/2014SE |
| K130079 | Multi-Parameter Mobile Careguide 3100 OximeterMUD · Traditional | Reflectance Medical, Inc. | 07/19/2013SE |
| K123700 | Fore-Sight Elite Absolute Tissue OximeterMUD · Traditional | Cas Medical Systems, Inc. | 04/11/2013SE |
| K122645 | Mobile Careguide 2100 OximeterMUD · Traditional | Reflectance Medical, Inc. | 12/05/2012SE |
| K112826 | Noorvms-Oxy Tissue Oxygen and Temperture MonitorMUD · Traditional | Moor Instruments, Ltd. | 10/10/2012SE |
| K113507 | Kent CameraMUD · Traditional | Kent Imaging, Inc. | 08/08/2012SE |
| K113656 | Careguide OximeterMUD · Traditional | Reflectance Medical, Inc. | 07/26/2012SE |
| K113215 | Model 7600 Regional Oximeter System with Equanox TechnologyMUD · Traditional | Nonin Medical, Inc. | 05/14/2012SE |
| K112820 | Fore-Sight Absolute Tissue OximeterMUD · Traditional | Cas Medical Systems, Inc. | 01/26/2012SE |
| K103613 | Inpectra STO2 Spot CheckMUD · Traditional | Hutchinson Technology, Inc. | 03/02/2011SE |
| K100875 | Cerox, Model 321OFMUD · Traditional | Or-Nim Medical , Ltd. | 01/25/2011SE |
| K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000…MUD · Traditional | Cas Medical Systems, Inc. | 12/23/2010SE |
| K102715 | Regional OximeterMUD · Traditional | Nonin Medical, Inc. | 12/17/2010SE |
| K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650MUD · Special | Hutchinson Technology, Inc. | 04/30/2010SE |
| K093923 | Cerox Model 3210MUD · Special | Or-Nim Medical , Ltd. | 01/19/2010SE |
| K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)MUD · Traditional | Cas Medical Systems, Inc. | 08/21/2009SE |
| K091224 | Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: Is-C and Is-SMUD · Special | Somanetics Corp. | 07/09/2009SE |
| K090807 | Regional Oximeter System, Model 7600MUD · Traditional | Nonin Medical, Inc. | 06/30/2009SE |
| K082327 | Invos Cerebral/Somatic Oximeter System, Model: 5100CMUD · Traditional | Somanetics Corp. | 04/03/2009SE |
| K081233 | T-Stat 303 Ischemia Monitoring SystemMUD · Special | Spectros Corporation | 07/28/2008SE |
| K080769 | Invos Cerebral/Somatic Oximeter System, Model 5100CMUD · Traditional | Somanetics Corp. | 05/14/2008SE |
| K073407 | PacificaMUD · Traditional | Or-Nim Medical , Ltd. | 02/28/2008SE |
| K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement SystemMUD · Special | Hypermed, Inc. | 01/25/2008SE |
| K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1MUD · Traditional | Hypermed, Inc. | 11/08/2006SE |
| K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040MUD · Traditional | Cas Medical Systems, Inc. | 09/05/2006SE |
| K061619 | Inspectra STO2 Tissue Oxygenation MonitorMUD · Traditional | Hutchinson Technology, Inc. | 07/12/2006SE |
| K053618 | Inspectra Tissue Spectrometer System, Model 325MUD · Traditional | Hutchinson Technology, Inc. | 02/08/2006SE |
| K051274 | Invos SystemMUD · Traditional | Somanetics Corp. | 11/04/2005SE |
| K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model OXY-2MUD · Traditional | Vioptix, Inc. | 01/10/2005SE |
| K040684 | T-Stat Microvascular Tissue Oximeter, Model 303MUD · Traditional | Spectros Corporation | 11/05/2004SE |
| K042020 | Spectra Tissue Spectrometer System (Inspectra)MUD · Traditional | Hutchinson Technology, Inc. | 09/15/2004SE |
| K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325MUD · Special | Hutchinson Technology, Inc. | 12/13/2002SE |
| K012759 | Inspectra Tissue Spectrometer System (Inspectra), Model 325MUD · Traditional | Hutchinson Technology, Inc. | 01/17/2002SE |
| K963903 | Biospectrometer-Nb Oximeter IiiiMUD · Traditional | Hutchinson Technology, Inc. | 01/27/1998SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3250-2026 | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The…Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. | Becton, Dickinson and Company | 08/11/2026Open, Classified |
| Z-1732-2024 Class II | Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSCmanufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | Covidien | 01/09/2024Open, Classified |
| Z-1731-2024 Class II | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RICmanufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | Covidien | 01/09/2024Open, Classified |
| Z-0789-2024 Class II | Snapshot NIR, REF: KD204Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of… | Kent Imaging, Inc. | 10/30/2023Open, Classified |
| Z-0835-2022 Class II | FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the… | Edwards Lifesciences, LLC | 03/01/2022Open, Classified |
| Z-0834-2022 Class II | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA.…The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the… | Edwards Lifesciences, LLC | 03/01/2022Open, Classified |
| Z-0458-2010 | Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional…A malfunction was detected with one of the components that, under rare circumstances, may result in the… | Nonin Medical, Inc | 10/23/2009Terminated |