# K102715: Regional Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Dec 17, 2010 after 88 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: 10 generations back to K931154 (1993). 40 ancestors in all.
53 later devices descend from it; 6 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090807: Regional Oximeter System, Model 7600, Nonin Medical, Inc. (2009) Summary page 1.
- K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030), Cas Medical Systems, Inc. (2009) Summary page 1.
- K051274: Invos System, Somanetics Corp. (2005) Summary page 1.

## Most influential descendants
- K133879: Fore-Sight Elite Absolute Tissue Oximeter (2014), 44 descendants of its own
- K113215: Model 7600 Regional Oximeter System with Equanox Technology (2012), 42 descendants of its own
- K143675: FORE-SIGHT Elite Absolute Tissue Oximeter (2015), 37 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K180003: FORE-SIGHT ELITE Module Tissue Oximeter (2018), 29 descendants of its own

## Indications for use
Model 7600 Regional Oximeter System: Nonin’s non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments. Model 8004CA Regional Sensor: The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments. Model 8000CA Regional Oximeter Sensor: The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Source page: https://510kreport.com/device/K102715
Methodology: https://510kreport.com/methodology