# K141496: Multi-Parameter Mobile Careguide 4100 Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Reflectance Medical, Inc.
- Decided: Aug 4, 2014 after 59 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: 12 generations back to K963903 (1998). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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) Summary page 5.
- K122645: Mobile Careguide 2100 Oximeter, Reflectance Medical, Inc. (2012) Summary page 5.
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter, Reflectance Medical, Inc. (2013) Summary page 5.
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet, Reflectance Medical, Inc. (2014) Summary page 5.

## Indications for use
The Multi-Parameter Mobile CareGuide™ 4100 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 4100 Oximeter is intended to allow for display of SmO2 and pHm data on a third party or Reflectance supplied device, which would interface with the Multi-Parameter Mobile CareGuide 4100 Oximeter via a powered USB connection. The Multi-Parameter Mobile CareGuide 4100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional inside and outside a hospital. The Multi-Parameter Mobile CareGuide 4100 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 4100 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 4100 Oximeter has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K141496
Methodology: https://510kreport.com/methodology