# K122645: Mobile Careguide 2100 Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Reflectance Medical, Inc.
- Decided: Dec 5, 2012 after 97 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: 9 generations back to K963903 (1998). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113656: Careguide Oximeter, Reflectance Medical, Inc. (2012)

## Most influential descendants
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter (2013), 2 descendants of its own
- 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 Mobile CareGuide T' 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K122645
Methodology: https://510kreport.com/methodology