T-Stat Microvascular Tissue Oximeter, Model 303

Q: What is the product code of K040684?

The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.

FDA 510(k) K040684 · Spectros Corporation

Substantially Equivalent

510(k) numberK040684

Submission

Device name: T-Stat Microvascular Tissue Oximeter, Model 303
Applicant: Spectros Corporation
Portola Valley, CA, US
Received: March 16, 2004
Decision date: November 5, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MUD – Oximeter, Tissue Saturation
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2700
Specialty: Cardiovascular

Other 510(k)s with product code MUD

510(k)	Device	Applicant	Decision
K254129	Spectrum-2MUD · Traditional	Neko Health AB	05/22/2026SE
K243324	Masimo O3 Regional OximeterMUD · Traditional	Masimo Corporation	07/17/2025SE
K250519	Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional	ViOptix, Inc.	06/26/2025SE
K240596	Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional	Edwards Lifesciences	10/16/2024SE
K241393	ODI-TechMUD · Traditional	Odi Medical AS	08/30/2024SE
K240601	SnapshotNIR model KD205MUD · Traditional	Kent Imaging, Inc.	04/02/2024SE
K232385	OxiplexTS200MUD · Traditional	Iss Medical, Inc.	03/01/2024SE
K233488	Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional	Vioptix, Inc.	02/28/2024SE
K230612	Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional	Edwards Lifesciences, LLC	11/17/2023SE
K223651	Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional	Edwards Lifesciences, LLC	05/26/2023SE

More from Edwards Lifesciences, LLC

510(k)	Device	Decision
K192322	T-Stat 2.0 Microvascular Tissue OximeterMUD · Special	09/23/2019SE
K081233	T-Stat 303 Ischemia Monitoring SystemMUD · Special	07/28/2008SE

Questions and answers

When was T-Stat Microvascular Tissue Oximeter, Model 303 cleared by the FDA?

T-Stat Microvascular Tissue Oximeter, Model 303 (K040684) received a 510(k) decision of Substantially Equivalent on November 5, 2004, 234 days after the submission was received.

What is the product code of K040684?

The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.