# K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325

- Pathway: 510(k) (Traditional)
- Applicant: Hutchinson Technology, Inc.
- Decided: Jan 17, 2002 after 153 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: 1 generation back to K963903 (1998). 1 ancestor in all.
99 later devices descend from it; 5 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)
- K963903: Biospectrometer-NB Oximeter Iiii, Hutchinson Technology, Inc. (1998) Summary page 1.

## Most influential descendants
- K023938: Modification to Inspectra Tissue Spectrometer System, Model 325 (2002), 98 descendants of its own
- 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

## Indications for use
Hutchinson Technology Incorporated’s InSpectra™ Tissue Spectrometer System, Model 325, is a non-invasive monitoring system that measures an approximated value of percent hemoglobin oxygen saturation in tissue (StO,). The InSpectra™ Tissue Spectrometer with 12 to 26 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 InSpectra™ Tissue 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/K012759
Methodology: https://510kreport.com/methodology