Devices descending from K023938
98 later devices reach Modification to Inspectra Tissue Spectrometer System, Model 325 through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K061848 | Hyperspectral Tissue Oxygenation Measurement System, Model Oxy VU1 | Hypermed, Inc. | 2006 | 9 | — |
| +1 | K042657 | Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2 | Vioptix, Inc. | 2005 | 9 | — |
| +1 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | 67 | — |
| +1 | K042020 | Spectra Tissue Spectrometer System (Inspectra) | Hutchinson Technology, Inc. | 2004 | 76 | — |
| +2 | K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024 | 0 | — |
| +2 | K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | 2019 | 0 | — |
| +2 | K133983 | Intra. OX Handheld Tissue Oximeter | Vioptix, Inc. | 2014 | 5 | — |
| +2 | K141234 | Odissey Tissue Oximeter | Vioptix, Inc. | 2014 | 0 | — |
| +2 | K112826 | Noorvms-Oxy Tissue Oxygen and Temperture Monitor | Moor Instruments, Ltd. | 2012 | 0 | — |
| +2 | K113507 | Kent Camera | Kent Imaging, Inc. | 2012 | 3 | — |
| +2 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | 57 | — |
| +2 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | 58 | — |
| +2 | K081233 | T-Stat 303 Ischemia Monitoring System | Spectros Corporation | 2008 | 56 | — |
| +2 | K073036 | Fore-Sight, MC-2000 Series | Cas Medical Systems, Inc. | 2008 | 59 | — |
| +2 | K073656 | Oxyvu -1 Hyperspectral Tissue Oxygenation (Hto) Measurement System | Hypermed, Inc. | 2008 | 8 | — |
| +2 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | 59 | — |
| +2 | K053618 | Inspectra Tissue Spectrometer System, Model 325 | Hutchinson Technology, Inc. | 2006 | 75 | — |
| +2 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | 63 | — |
| +3 | K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019 | 0 | — |
| +3 | K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | 2018 | 0 | — |
| +3 | K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017 | 4 | — |
| +3 | K163070 | Kent Camera | Kent Imaging, Inc. | 2017 | 1 | — |
| +3 | K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016 | 2 | — |
| +3 | K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement System | Hypermed Imaging, Inc. | 2016 | 0 | — |
| +3 | K094030 | Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000… | Cas Medical Systems, Inc. | 2010 | 53 | — |
| +3 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | 53 | — |
| +3 | K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650 | Hutchinson Technology, Inc. | 2010 | 61 | — |
| +3 | K073407 | Pacifica | Or-Nim Medical, Ltd. | 2008 | 1 | — |
| +3 | K061619 | Inspectra STO2 Tissue Oxygenation Monitor | Hutchinson Technology, Inc. | 2006 | 64 | — |
| +4 | K201976 | SnapshotNIR | Kent Imaging | 2020 | 0 | 1 |
| +4 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019 | 3 | — |
| +4 | K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI… | Nonin Medical, Inc. | 2019 | 0 | — |
| +4 | K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018 | 1 | — |
| +4 | K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model… | Nonin Medical, Inc. | 2015 | 1 | — |
| +4 | K133879 | Fore-Sight Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2014 | 44 | — |
| +4 | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | 3 | 1 |
| +4 | K123700 | Fore-Sight Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2013 | 0 | — |
| +4 | K113215 | Model 7600 Regional Oximeter System with Equanox Technology | Nonin Medical, Inc. | 2012 | 42 | — |
| +4 | K112820 | Fore-Sight Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2012 | 47 | — |
| +4 | K103613 | Inpectra STO2 Spot Check | Hutchinson Technology, Inc. | 2011 | 5 | — |
| +4 | K093923 | Cerox Model 3210 | Or-Nim Medical, Ltd. | 2010 | 0 | — |
| +5 | K254129 | Spectrum-2 | Neko Health AB | 2026 | 0 | — |
| +5 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022 | 2 | — |
| +5 | K192900 | H500 Multi-Sensing Oximetry System | Nonin Medical, Inc. | 2020 | 0 | — |
| +5 | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series… | Nonin Medical, Inc. | 2016 | 1 | — |
| +5 | K160526 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2016 | 5 | — |
| +5 | K150268 | CerOX | Or-Nim Medical, Ltd. | 2015 | 0 | — |
| +5 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015 | 37 | 1 |
| +5 | K113656 | Careguide Oximeter | Reflectance Medical, Inc. | 2012 | 4 | — |
| +6 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | 0 | — |
| +6 | K233488 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024 | 1 | — |
| +6 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +6 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +6 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +6 | K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019 | 3 | — |
| +6 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | 29 | 1 |
| +6 | K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017 | 0 | — |
| +6 | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | 2014 | 0 | — |
| +6 | K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet | Reflectance Medical, Inc. | 2014 | 1 | — |
| +6 | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | 2 | — |
| +6 | K122645 | Mobile Careguide 2100 Oximeter | Reflectance Medical, Inc. | 2012 | 3 | — |
| +7 | K250519 | Lap.Ox™ Laparoscopic Tissue Oximeter | Vioptix, Inc. | 2025 | 0 | — |
| +7 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +7 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +7 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +7 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +7 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +7 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +8 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +8 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +8 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +8 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +8 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +8 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +8 | K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022 | 1 | — |
| +8 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +8 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +8 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |
| +8 | K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction… | Edwards Lifesciences, LLC | 2021 | 18 | — |
| +9 | K260008 | Deterioration Index Version 2 | Epic Systems Corporation | 2026 | 0 | — |
| +9 | K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025 | 0 | — |
| +9 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere… | Edwards Lifesciences | 2025 | 2 | 1 |
| +9 | K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025 | 0 | — |
| +9 | K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +9 | K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart… | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +9 | K230842 | SignalHF (IM008) | Implicity, Inc. | 2023 | 0 | — |
| +9 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | Edwards Lifesciencess, LLC | 2023 | 6 | 2 |
| +9 | K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid… | Edwards Lifesciences, LLC | 2023 | 7 | — |
| +9 | K230057 | Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +9 | K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +9 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion… | Edwards Lifesciences, LLC | 2022 | 6 | — |
| +9 | K221203 | AHI System | Fifth Eye, Inc. | 2022 | 0 | — |
| +10 | K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +10 | K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | 2026 | 0 | — |
| +10 | K253034 | HemoSphere Stream Module | Edwards Lifesciences | 2025 | 0 | — |
| +10 | K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025 | 0 | — |
| +10 | K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024 | 0 | — |
| +10 | K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024 | 0 | — |