ClearanceBrief
Panels › Cardiovascular › Product code MUD · Class 2

Oximeter, Tissue Saturation

Regulation 870.2700

1510(k)s in 12 months (74 all time)
1recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in MUD

Company510(k)sRecalls
Cas Medical Systems, Inc.90
Hutchinson Technology, Inc.80
ViOptix, Inc.80
Edwards Lifesciences42
Masimo Corporation60
Nonin Medical, Inc.51
Kent Imaging41
Reflectance Medical, Inc.50
Covidien, LLC22
Somanetics Corp.40
Decided510(k)Device and applicantCode
May 22, 2026K254129Spectrum-2
Neko Health AB, SE
MUD
Jul 17, 2025K243324Masimo O3 Regional Oximeter
Masimo Corporation
MUD
Jun 26, 2025K250519Lap.Ox™ Laparoscopic Tissue Oximeter
ViOptix, Inc.
MUD
Oct 16, 2024K240596Cerebral Autoregulation Index (CAI) Algorithm
Edwards Lifesciences
MUD
Aug 30, 2024K241393ODI-Tech
Odi Medical AS, NO
MUD
Apr 2, 2024K240601SnapshotNIR model KD205
Kent Imaging, Inc., CA
MUD
Mar 1, 2024K232385OxiplexTS200
Iss Medical, Inc.
MUD
Feb 28, 2024K233488Intra.Ox™ 2.0 Handheld Tissue Oximeter
Vioptix, Inc.
MUD
Nov 17, 2023K230612Edwards Algorithm for Measurement of Blood Hemoglobin
Edwards Lifesciences, LLC
MUD
May 26, 2023K223651Cerebral Adaptive Index (CAI) Algorithm
Edwards Lifesciences, LLC
MUD
May 6, 2022K214072Masimo O3 Regional Oximeter System
Masimo Corporation
MUD
May 3, 2022K221010Intra.Ox 2.0 Handheld Tissue Oximeter
Vioptix, Inc.
MUD
Dec 5, 2021K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as
Covidien, LLC
MUD
Feb 10, 2021K203490FORE-SIGHT ELITE Absolute Tissue Oximeter
Edwards Lifesciences, LLC
MUD
Nov 10, 2020K201976SnapshotNIR
Kent Imaging, CA
MUD
Aug 29, 2020K201432Masimo O3 Regional Oximeter System
Masimo Corporation
MUD
Nov 1, 2019K190334MIMOSA Imager
Mimosa Diagnostics, Inc., CA
MUD
Oct 21, 2019K190270FORE-SIGHT ELITE Tissue Oximeter Module
Cas Medical Systems, Inc.
MUD
Sep 23, 2019K192322T-Stat 2.0 Microvascular Tissue Oximeter
Spectros Corporation
MUD
Sep 16, 2019K191676Intra.Ox 2.0 Handheld Tissue Oximeter
Vioptix, Inc.
MUD
Jun 7, 2019K182429Masimo O3 Regional Oximeter System
Masimo Corporation
MUD
May 2, 2019K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
Nonin Medical, Inc.
MUD
Jan 8, 2019K182868INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Covidien, LLC
MUD
Aug 9, 2018K171245Presygen/si-1
Christie Medical Holdings, Inc.
MUD
Jul 19, 2018K181623Clarifi Imaging System
Modulated Imaging, Inc.
MUD
May 10, 2018K180003FORE-SIGHT ELITE Module Tissue Oximeter
Cas Medical Systems, Inc.
MUD
Nov 16, 2017K163472Intra.Ox Handheld Tissue Oximeter
Vioptix, Inc.
MUD
May 26, 2017K162603Masimo O3 Regional Oximeter System
Masimo Corporation
MUD
May 5, 2017K163070Kent Camera
Kent Imaging, Inc., CA
MUD
Dec 21, 2016K153426Ox-Imager CS
Modulated Imaging, Inc.
MUD
Dec 16, 2016K161237HyperView Hyperspectral Tissue Oxygenation Measurement System
Hypermed Imaging, Inc.
MUD
Oct 25, 2016K162117NIRO-200NX DP
Hamamatsu Photonics K.K., JP
MUD
Jun 9, 2016K160526Masimo O3 Regional Oximeter System
Masimo Corporation
MUD
Aug 27, 2015K151305SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (
Nonin Medical, Inc.
MUD
Jul 31, 2015K143219NIRO-200NX
Hamamatsu Photonics K.K., JP
MUD
Apr 10, 2015K143675FORE-SIGHT Elite Absolute Tissue Oximeter
Cas Medical Systems, Inc.
MUD
Sep 12, 2014K133983INTRA. OX HANDHELD TISSUE OXIMETER
Vioptix, Inc.
MUD
Aug 4, 2014K141496MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETER
Reflectance Medical, Inc.
MUD
Jul 1, 2014K141234ODISSEY TISSUE OXIMETER
Vioptix, Inc.
MUD
Apr 29, 2014K133879FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
Cas Medical Systems, Inc.
MUD
Apr 11, 2014K133923MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
Reflectance Medical, Inc.
MUD
Jul 19, 2013K130079MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER
Reflectance Medical, Inc.
MUD
Apr 11, 2013K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
Cas Medical Systems, Inc.
MUD
Dec 5, 2012K122645MOBILE CAREGUIDE 2100 OXIMETER
Reflectance Medical, Inc.
MUD
Oct 10, 2012K112826NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
Moor Instruments, Ltd., GB
MUD
Aug 8, 2012K113507KENT CAMERA
Kent Imaging, Inc., CA
MUD
Jul 26, 2012K113656CAREGUIDE OXIMETER
Reflectance Medical, Inc.
MUD
May 14, 2012K113215MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY
Nonin Medical, Inc.
MUD
Jan 26, 2012K112820FORE-SIGHT ABSOLUTE TISSUE OXIMETER
Cas Medical Systems, Inc.
MUD
Mar 2, 2011K103613INPECTRA STO2 SPOT CHECK
Hutchinson Technology, Inc.
MUD

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