| Spectrum-2 (K254129) | Neko Health AB | 2026-05-22 |
| Masimo O3 Regional Oximeter (K243324) | Masimo Corporation | 2025-07-17 |
| Lap.Ox™ Laparoscopic Tissue Oximeter (K250519) | ViOptix, Inc. | 2025-06-26 |
| Cerebral Autoregulation Index (CAI) Algorithm (K240596) | Edwards Lifesciences | 2024-10-16 |
| ODI-Tech (K241393) | Odi Medical AS | 2024-08-30 |
| SnapshotNIR model KD205 (K240601) | Kent Imaging, Inc. | 2024-04-02 |
| OxiplexTS200 (K232385) | Iss Medical, Inc. | 2024-03-01 |
| Intra.Ox™ 2.0 Handheld Tissue Oximeter (K233488) | Vioptix, Inc. | 2024-02-28 |
| Edwards Algorithm for Measurement of Blood Hemoglobin (K230612) | Edwards Lifesciences, LLC | 2023-11-17 |
| Cerebral Adaptive Index (CAI) Algorithm (K223651) | Edwards Lifesciences, LLC | 2023-05-26 |
| Masimo O3 Regional Oximeter System (K214072) | Masimo Corporation | 2022-05-06 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K221010) | Vioptix, Inc. | 2022-05-03 |
| INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) | Covidien, LLC | 2021-12-05 |
| FORE-SIGHT ELITE Absolute Tissue Oximeter (K203490) | Edwards Lifesciences, LLC | 2021-02-10 |
| SnapshotNIR (K201976) | Kent Imaging | 2020-11-10 |
| Masimo O3 Regional Oximeter System (K201432) | Masimo Corporation | 2020-08-29 |
| MIMOSA Imager (K190334) | Mimosa Diagnostics, Inc. | 2019-11-01 |
| FORE-SIGHT ELITE Tissue Oximeter Module (K190270) | Cas Medical Systems, Inc. | 2019-10-21 |
| T-Stat 2.0 Microvascular Tissue Oximeter (K192322) | Spectros Corporation | 2019-09-23 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K191676) | Vioptix, Inc. | 2019-09-16 |
| Masimo O3 Regional Oximeter System (K182429) | Masimo Corporation | 2019-06-07 |
| SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface (K190560) | Nonin Medical, Inc. | 2019-05-02 |
| INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor (K182868) | Covidien, LLC | 2019-01-08 |
| Presygen/si-1 (K171245) | Christie Medical Holdings, Inc. | 2018-08-09 |
| Clarifi Imaging System (K181623) | Modulated Imaging, Inc. | 2018-07-19 |
| FORE-SIGHT ELITE Module Tissue Oximeter (K180003) | Cas Medical Systems, Inc. | 2018-05-10 |
| Intra.Ox Handheld Tissue Oximeter (K163472) | Vioptix, Inc. | 2017-11-16 |
| Masimo O3 Regional Oximeter System (K162603) | Masimo Corporation | 2017-05-26 |
| Kent Camera (K163070) | Kent Imaging, Inc. | 2017-05-05 |
| Ox-Imager CS (K153426) | Modulated Imaging, Inc. | 2016-12-21 |
| HyperView Hyperspectral Tissue Oxygenation Measurement System (K161237) | Hypermed Imaging, Inc. | 2016-12-16 |
| NIRO-200NX DP (K162117) | Hamamatsu Photonics K.K. | 2016-10-25 |
| Masimo O3 Regional Oximeter System (K160526) | Masimo Corporation | 2016-06-09 |
| SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) (K151305) | Nonin Medical, Inc. | 2015-08-27 |
| NIRO-200NX (K143219) | Hamamatsu Photonics K.K. | 2015-07-31 |
| FORE-SIGHT Elite Absolute Tissue Oximeter (K143675) | Cas Medical Systems, Inc. | 2015-04-10 |
| INTRA. OX HANDHELD TISSUE OXIMETER (K133983) | Vioptix, Inc. | 2014-09-12 |
| MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER (K141496) | Reflectance Medical, Inc. | 2014-08-04 |
| ODISSEY TISSUE OXIMETER (K141234) | Vioptix, Inc. | 2014-07-01 |
| FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K133879) | Cas Medical Systems, Inc. | 2014-04-29 |
| MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET (K133923) | Reflectance Medical, Inc. | 2014-04-11 |
| MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER (K130079) | Reflectance Medical, Inc. | 2013-07-19 |
| FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700) | Cas Medical Systems, Inc. | 2013-04-11 |
| MOBILE CAREGUIDE 2100 OXIMETER (K122645) | Reflectance Medical, Inc. | 2012-12-05 |
| NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR (K112826) | Moor Instruments, Ltd. | 2012-10-10 |
| KENT CAMERA (K113507) | Kent Imaging, Inc. | 2012-08-08 |
| CAREGUIDE OXIMETER (K113656) | Reflectance Medical, Inc. | 2012-07-26 |
| MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY (K113215) | Nonin Medical, Inc. | 2012-05-14 |
| FORE-SIGHT ABSOLUTE TISSUE OXIMETER (K112820) | Cas Medical Systems, Inc. | 2012-01-26 |
| INPECTRA STO2 SPOT CHECK (K103613) | Hutchinson Technology, Inc. | 2011-03-02 |
| CEROX, MODEL 321OF (K100875) | Or-Nim Medical , Ltd. | 2011-01-25 |
| FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 (K094030) | Cas Medical Systems, Inc. | 2010-12-23 |
| REGIONAL OXIMETER (K102715) | Nonin Medical, Inc. | 2010-12-17 |
| INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 (K100915) | Hutchinson Technology, Inc. | 2010-04-30 |
| CEROX MODEL 3210 (K093923) | Or-Nim Medical , Ltd. | 2010-01-19 |
| FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) (K091452) | Cas Medical Systems, Inc. | 2009-08-21 |
| OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S (K091224) | Somanetics Corp. | 2009-07-09 |
| REGIONAL OXIMETER SYSTEM, MODEL 7600 (K090807) | Nonin Medical, Inc. | 2009-06-30 |
| INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C (K082327) | Somanetics Corp. | 2009-04-03 |
| T-STAT 303 ISCHEMIA MONITORING SYSTEM (K081233) | Spectros Corporation | 2008-07-28 |
| INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C (K080769) | Somanetics Corp. | 2008-05-14 |
| PACIFICA (K073407) | Or-Nim Medical , Ltd. | 2008-02-28 |
| OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM (K073656) | Hypermed, Inc. | 2008-01-25 |
| HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 (K061848) | Hypermed, Inc. | 2006-11-08 |
| FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 (K061960) | Cas Medical Systems, Inc. | 2006-09-05 |
| INSPECTRA STO2 TISSUE OXYGENATION MONITOR (K061619) | Hutchinson Technology, Inc. | 2006-07-12 |
| INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K053618) | Hutchinson Technology, Inc. | 2006-02-08 |
| INVOS SYSTEM (K051274) | Somanetics Corp. | 2005-11-04 |
| VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 (K042657) | Vioptix, Inc. | 2005-01-10 |
| T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 (K040684) | Spectros Corporation | 2004-11-05 |
| SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) (K042020) | Hutchinson Technology, Inc. | 2004-09-15 |
| MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 (K023938) | Hutchinson Technology, Inc. | 2002-12-13 |
| INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 (K012759) | Hutchinson Technology, Inc. | 2002-01-17 |
| BIOSPECTROMETER-NB OXIMETER IIII (K963903) | Hutchinson Technology, Inc. | 1998-01-27 |