Spectra Tissue Spectrometer System (Inspectra)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042020 ↗

FDA Product Code

MUD

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Inpectra STO2 Spot Check

  Class II

  FDA 510(k) K103613 Active Cleared 2 Mar 2011

• Biospectrometer-Nb Oximeter Iiii

  Class II

  FDA 510(k) K963903 Active Cleared 27 Jan 1998

• Inspectra STO2 Tissue Oxygenation Monitor

  Class II

  FDA 510(k) K061619 Active Cleared 12 Jul 2006

• Inspectra Tissue Spectrometer System (Inspectra), Model 325

  Class II

  FDA 510(k) K012759 Active Cleared 17 Jan 2002

• Modification to Inspectra Tissue Spectrometer System, Model 325

  Class II

  FDA 510(k) K023938 Active Cleared 13 Dec 2002

• Inspectra STO2 Tissue Oxygenation Monitor, Model 650

  Class II

  FDA 510(k) K100915 Active Cleared 30 Apr 2010

See all devices from Hutchinson Technology, Inc. →

• What is the Spectra Tissue Spectrometer System (InSpectra) Model 325 used for?

  The InSpectra Model 325 is a non-invasive tissue oximeter designed to measure tissue hemoglobin oxygen saturation (StO₂) in real-time. It is particularly useful for assessing oxygenation levels in soft tissues, making it valuable in cardiovascular assessments and perfusion studies. This helps clinicians monitor tissue health and circulation without invasive procedures.

• Is the InSpectra Model 325 reusable or single-use?

  The InSpectra Model 325 is supplied as a reusable medical instrument. It is intended for use in clinical settings such as operating rooms, intensive care units, or diagnostic labs, where proper calibration and maintenance are required to ensure accurate and reliable performance.

• Does the InSpectra Model 325 have any MRI restrictions?

  No, the InSpectra Model 325 operates without MRI restrictions. This means it can be used safely in environments where MRI scans are performed, provided standard electromagnetic interference guidelines are followed.

• What regulatory approval does the InSpectra Model 325 hold?

  The InSpectra Model 325 is authorized for use in the United States under FDA 510(k) clearance (K042020). It adheres to regulatory standards for Class II devices, specifically under regulation number 870.2700, ensuring it meets the necessary safety and performance requirements for clinical use.

• What maintenance or calibration is required for the InSpectra Model 325?

  The InSpectra Model 325 requires proper calibration and maintenance as outlined by the manufacturer’s guidelines. Regular calibration ensures the device’s accuracy in measuring tissue oxygen saturation, while maintenance protocols help sustain its performance and reliability in clinical settings.