# K123700: Fore-Sight Elite Absolute Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Apr 11, 2013 after 129 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 K931154 (1993). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112820: Fore-Sight Absolute Tissue Oximeter, Cas Medical Systems, Inc. (2012)
- K102715: Regional Oximeter, Nonin Medical, Inc. (2010) Summary page 2.

## Indications for use
The noninvasive FORE-SIGHT Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow isehemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and tranisitional adolescents ?! 40 kg.

Source page: https://510kreport.com/device/K123700
Methodology: https://510kreport.com/methodology