# K133879: Fore-Sight Elite Absolute Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Apr 29, 2014 after 130 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.
44 later devices descend from it; 2 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K143675: FORE-SIGHT Elite Absolute Tissue Oximeter (2015), 37 descendants of its own
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own
- K180003: FORE-SIGHT ELITE Module Tissue Oximeter (2018), 29 descendants of its own
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module (2020), 27 descendants of its own
- K203687: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (2021), 18 descendants of its own

## 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 ischemic states and is indicated for use as follows: When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on adults and transitional adolescents > 40 kg.

Source page: https://510kreport.com/device/K133879
Methodology: https://510kreport.com/methodology