# K190270: FORE-SIGHT ELITE Tissue Oximeter Module

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Oct 21, 2019 after 255 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: 15 generations back to K931154 (1993). 53 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180003: FORE-SIGHT ELITE Module Tissue Oximeter, Cas Medical Systems, Inc. (2018) Summary page 5.

## Most influential descendants
- K213682: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (2022), 14 descendants of its own
- K223865: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor (2023), 7 descendants of its own
- K223651: Cerebral Adaptive Index (CAI) Algorithm (2023), 6 descendants of its own
- K223127: HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable (2022), 6 descendants of its own
- K230612: Edwards Algorithm for Measurement of Blood Hemoglobin (2023), 5 descendants of its own

## Indications for use
The noninvasive FORE-SIGHT ELITE Tissue Oximeter “Module” 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. The Module is also intended for use as an adjunct monitor of relative changes of oxygenated hemoglobin, deoxygenated hemoglobin, and their summation, total hemoglobin, of blood under the sensors. The Module is intended to allow for the display of StO2 and regional hemoglobin on a third party display/patient monitor and is indicated for use as follows: When used with large sensors, the Module is indicated for use on adults and transitional adolescents >40 kg. When used with medium sensors, the Module is indicated for use on pediatric subjects >3 kg. When used with small sensors, the Module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects < 5kg,

Source page: https://510kreport.com/device/K190270
Methodology: https://510kreport.com/methodology