# K130079: Multi-Parameter Mobile Careguide 3100 Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Reflectance Medical, Inc.
- Decided: Jul 19, 2013 after 186 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 K963903 (1998). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970906: Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor, Diametrics Medical, Ltd. (1997) Summary page 4.
- K020967: Terumo Khuri Myocardial PH Monitoring System, Terumo Cardiovascular Systems Corp. (2002) Summary page 2.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 2.
- K061204: Masimo Set Radical 7 Pulse CO-Oximeter, Masimo Corporation (2006) Summary page 2.
- K113656: Careguide Oximeter, Reflectance Medical, Inc. (2012) Summary page 2.
- K122645: Mobile Careguide 2100 Oximeter, Reflectance Medical, Inc. (2012) Summary page 2.

## Most influential descendants
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet (2014), 1 descendant of its own
- K141496: Multi-Parameter Mobile Careguide 4100 Oximeter (2014), 0 descendants of its own

## Indications for use
The Multi-Parameter Mobile CareGuideTM 3100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation and pH of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended to allow for display of SmO2 and pHmn data on a third party device, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB or CAN connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter provides output of the most recent values of SmO2 and pHm in a trend, as well as operational device information. The Multi-Parameter Mobile CareGuide 3100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Multi-Parameter Mobile CareGuide 3100 Oximeter has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K130079
Methodology: https://510kreport.com/methodology