FDA Product Code
FDA Product Code MUD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254129 | Spectrum-2 | Neko Health AB | 2026-05-22 | Traditional | PDF ↗ |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | 2025-07-17 | Traditional | PDF ↗ |
| K250519 | Lap.Ox Laparoscopic Tissue Oximeter | ViOptix, Inc. | 2025-06-26 | Traditional | PDF ↗ |
| K240596 | Cerebral Autoregulation Index (CAI) Algorithm | Edwards Lifesciences | 2024-10-16 | Traditional | PDF ↗ |
| K241393 | ODI-Tech | Odi Medical AS | 2024-08-30 | Traditional | PDF ↗ |
| K240601 | SnapshotNIR model KD205 | Kent Imaging, Inc. | 2024-04-02 | Traditional | PDF ↗ |
| K232385 | OxiplexTS200 | Iss Medical, Inc. | 2024-03-01 | Traditional | PDF ↗ |
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2024-02-28 | Traditional | PDF ↗ |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023-11-17 | Traditional | PDF ↗ |
| K223651 | Cerebral Adaptive Index (CAI) Algorithm | Edwards Lifesciences, LLC | 2023-05-26 | Traditional | PDF ↗ |
| K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022-05-06 | Traditional | PDF ↗ |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2022-05-03 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021-02-10 | Traditional | PDF ↗ |
| K201976 | SnapshotNIR | Kent Imaging | 2020-11-10 | Traditional | PDF ↗ |
| K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020-08-29 | Traditional | PDF ↗ |
| K190334 | MIMOSA Imager | Mimosa Diagnostics, Inc. | 2019-11-01 | Traditional | PDF ↗ |
| K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019-10-21 | Traditional | PDF ↗ |
| K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | Spectros Corporation | 2019-09-23 | Special | PDF ↗ |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Vioptix, Inc. | 2019-09-16 | Traditional | PDF ↗ |
| K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019-06-07 | Traditional | PDF ↗ |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | Nonin Medical, Inc. | 2019-05-02 | Traditional | PDF ↗ |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | Covidien, LLC | 2019-01-08 | Traditional | PDF ↗ |
| K171245 | Presygen/si-1 | Christie Medical Holdings, Inc. | 2018-08-09 | Traditional | PDF ↗ |
| K181623 | Clarifi Imaging System | Modulated Imaging, Inc. | 2018-07-19 | Special | PDF ↗ |
| K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018-05-10 | Traditional | PDF ↗ |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Vioptix, Inc. | 2017-11-16 | Traditional | PDF ↗ |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017-05-26 | Traditional | PDF ↗ |
| K163070 | Kent Camera | Kent Imaging, Inc. | 2017-05-05 | Traditional | PDF ↗ |
| K153426 | Ox-Imager CS | Modulated Imaging, Inc. | 2016-12-21 | Traditional | PDF ↗ |
| K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement System | Hypermed Imaging, Inc. | 2016-12-16 | Traditional | PDF ↗ |
| K162117 | NIRO-200NX DP | Hamamatsu Photonics K.K. | 2016-10-25 | Traditional | PDF ↗ |
| K160526 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2016-06-09 | Traditional | PDF ↗ |
| K151305 | SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) | Nonin Medical, Inc. | 2015-08-27 | Traditional | PDF ↗ |
| K143219 | NIRO-200NX | Hamamatsu Photonics K.K. | 2015-07-31 | Traditional | PDF ↗ |
| K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter | Cas Medical Systems, Inc. | 2015-04-10 | Traditional | PDF ↗ |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | Vioptix, Inc. | 2014-09-12 | Traditional | PDF ↗ |
| K141496 | MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER | Reflectance Medical, Inc. | 2014-08-04 | Traditional | PDF ↗ |
| K141234 | ODISSEY TISSUE OXIMETER | Vioptix, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2014-04-29 | Traditional | PDF ↗ |
| K133923 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET | Reflectance Medical, Inc. | 2014-04-11 | Traditional | PDF ↗ |
| K130079 | MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER | Reflectance Medical, Inc. | 2013-07-19 | Traditional | PDF ↗ |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2013-04-11 | Traditional | PDF ↗ |
| K122645 | MOBILE CAREGUIDE 2100 OXIMETER | Reflectance Medical, Inc. | 2012-12-05 | Traditional | PDF ↗ |
| K112826 | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | Moor Instruments, Ltd. | 2012-10-10 | Traditional | PDF ↗ |
| K113507 | KENT CAMERA | Kent Imaging, Inc. | 2012-08-08 | Traditional | PDF ↗ |
| K113656 | CAREGUIDE OXIMETER | Reflectance Medical, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K113215 | MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY | Nonin Medical, Inc. | 2012-05-14 | Traditional | PDF ↗ |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | Cas Medical Systems, Inc. | 2012-01-26 | Traditional | PDF ↗ |
| K103613 | INPECTRA STO2 SPOT CHECK | Hutchinson Technology, Inc. | 2011-03-02 | Traditional | PDF ↗ |
| K100875 | CEROX, MODEL 321OF | Or-Nim Medical , Ltd. | 2011-01-25 | Traditional | PDF ↗ |
| K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | Cas Medical Systems, Inc. | 2010-12-23 | Traditional | PDF ↗ |
| K102715 | REGIONAL OXIMETER | Nonin Medical, Inc. | 2010-12-17 | Traditional | PDF ↗ |
| K100915 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 | Hutchinson Technology, Inc. | 2010-04-30 | Special | PDF ↗ |
| K093923 | CEROX MODEL 3210 | Or-Nim Medical , Ltd. | 2010-01-19 | Special | PDF ↗ |
| K091452 | FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009-08-21 | Traditional | PDF ↗ |
| K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S | Somanetics Corp. | 2009-07-09 | Special | PDF ↗ |
| K090807 | REGIONAL OXIMETER SYSTEM, MODEL 7600 | Nonin Medical, Inc. | 2009-06-30 | Traditional | PDF ↗ |
| K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C | Somanetics Corp. | 2009-04-03 | Traditional | PDF ↗ |
| K081233 | T-STAT 303 ISCHEMIA MONITORING SYSTEM | Spectros Corporation | 2008-07-28 | Special | PDF ↗ |
| K080769 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C | Somanetics Corp. | 2008-05-14 | Traditional | PDF ↗ |
| K073407 | PACIFICA | Or-Nim Medical , Ltd. | 2008-02-28 | Traditional | PDF ↗ |
| K073656 | OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM | Hypermed, Inc. | 2008-01-25 | Special | PDF ↗ |
| K061848 | HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 | Hypermed, Inc. | 2006-11-08 | Traditional | PDF ↗ |
| K061960 | FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 | Cas Medical Systems, Inc. | 2006-09-05 | Traditional | PDF ↗ |
| K061619 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR | Hutchinson Technology, Inc. | 2006-07-12 | Traditional | PDF ↗ |
| K053618 | INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | Hutchinson Technology, Inc. | 2006-02-08 | Traditional | PDF ↗ |
| K051274 | INVOS SYSTEM | Somanetics Corp. | 2005-11-04 | Traditional | PDF ↗ |
| K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | Vioptix, Inc. | 2005-01-10 | Traditional | PDF ↗ |
| K040684 | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 | Spectros Corporation | 2004-11-05 | Traditional | PDF ↗ |
| K042020 | SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) | Hutchinson Technology, Inc. | 2004-09-15 | Traditional | PDF ↗ |
| K023938 | MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | Hutchinson Technology, Inc. | 2002-12-13 | Special | PDF ↗ |
| K012759 | INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 | Hutchinson Technology, Inc. | 2002-01-17 | Traditional | PDF ↗ |
| K963903 | BIOSPECTROMETER-NB OXIMETER IIII | Hutchinson Technology, Inc. | 1998-01-27 | Traditional | PDF ↗ |
Product code MUD · Class II · Cardiovascular. Data: openFDA.