# K113656: Careguide Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Reflectance Medical, Inc.
- Decided: Jul 26, 2012 after 227 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: 8 generations back to K963903 (1998). 10 ancestors in all.
4 later devices descend from it; 4 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)
- K051274: Invos System, Somanetics Corp. (2005) Summary page 1.
- K012759: Inspectra Tissue Spectrometer System (Inspectra), Model 325, Hutchinson Technology, Inc. (2002) Summary page 2.
- K103613: Inpectra STO2 Spot Check, Hutchinson Technology, Inc. (2011) Summary page 2.

## Most influential descendants
- K122645: Mobile Careguide 2100 Oximeter (2012), 3 descendants of its own
- 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 CareGuide 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 CareGuide displays the most recent value of SmO2, as well as a graphical trend of previous SmO2 measurements. The CareGuide System should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the CareGuide Oximeter has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K113656
Methodology: https://510kreport.com/methodology