# K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet

- Pathway: 510(k) (Traditional)
- Applicant: Reflectance Medical, Inc.
- Decided: Apr 11, 2014 after 109 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: 11 generations back to K963903 (1998). 25 ancestors in all.
1 later device descends from it; 1 cites 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)
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter, Reflectance Medical, Inc. (2013) Summary page 2.
- K113656: Careguide Oximeter, Reflectance Medical, Inc. (2012) Summary page 2.

## Most influential descendants
- K141496: Multi-Parameter Mobile Careguide 4100 Oximeter (2014), 0 descendants of its own

## Indications for use
The Multi-Parameter Mobile CareGuideTM 3100 Oximeter with Tablet 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 pHm data on an Android Tablet display, which would interface with the Multi-Parameter Mobile CareGuide 3100 Oximeter via USB connection. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Multi-Parameter Mobile CareGuide 3100 Oximeter with Tablet provides display 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 with Tablet 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 with Tablet has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K133923
Methodology: https://510kreport.com/methodology