Product Code: MUD FDA class 2 21 CFR 870.2700

Oximeter, Tissue Saturation

Cardiovascular

A Tissue Saturation Oximeter is a non-invasive or minimally invasive monitoring device that measures regional oxygen saturation of tissue (rSO2) using near-infrared spectroscopy, providing real-time assessment of tissue oxygenation in organs such as the brain or muscles during surgery or critical care. It is FDA Class 2, requiring 510(k) clearance, with product code MUD under 21 CFR 870.2700 in the Cardiovascular specialty. The device is not an implant and is not life-sustaining.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MUD in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MUD
Device Class: FDA class 2
Regulation Number: 870.2700
Medical Specialty: Cardiovascular
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

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