# K042020: Spectra Tissue Spectrometer System (Inspectra)

- Pathway: 510(k) (Traditional)
- Applicant: Hutchinson Technology, Inc.
- Decided: Sep 15, 2004 after 50 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963903 (1998). 3 ancestors in all.
76 later devices descend from it; 2 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325, Hutchinson Technology, Inc. (2002) Summary page 1.

## Most influential descendants
- K053618: Inspectra Tissue Spectrometer System, Model 325 (2006), 75 descendants of its own
- K061619: Inspectra STO2 Tissue Oxygenation Monitor (2006), 64 descendants of its own
- K100915: Inspectra STO2 Tissue Oxygenation Monitor, Model 650 (2010), 61 descendants of its own
- K094030: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030 (2010), 53 descendants of its own
- K112820: Fore-Sight Absolute Tissue Oximeter (2012), 47 descendants of its own

## Indications for use
Hutchinson Technology Incorporated's InSpectraTM Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (PtO 2) The InSpectra TM Tissue Spectrometer is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The InSpectra TM Tissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity.

Source page: https://510kreport.com/device/K042020
Methodology: https://510kreport.com/methodology