# K023938: Modification to Inspectra Tissue Spectrometer System, Model 325

- Pathway: 510(k) (Special)
- Applicant: Hutchinson Technology, Inc.
- Decided: Dec 13, 2002 after 17 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: 2 generations back to K963903 (1998). 2 ancestors in all.
98 later devices descend from it; 4 cite it directly.
0 of 101 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)

## Most influential descendants
- K042020: Spectra Tissue Spectrometer System (Inspectra) (2004), 76 descendants of its own
- K053618: Inspectra Tissue Spectrometer System, Model 325 (2006), 75 descendants of its own
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303 (2004), 67 descendants of its own
- K061619: Inspectra STO2 Tissue Oxygenation Monitor (2006), 64 descendants of its own
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own

## Indications for use
Hutchinson Technology Incorporated's lnSpectraTMTissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (St02). The lnSpectraTMTissue Spectrometer with 12 to 25 mm probes 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 lnSpectraTMTissue Spectrometer System is intended to noninvasively and continuously measure hemoglobin oxygen saturation: in the upper extremity, shoulder, or lower extremity with 12 mm to 25 mm probes. The value of these measurements in disease states has not been demonstrated.

Source page: https://510kreport.com/device/K023938
Methodology: https://510kreport.com/methodology