# K203490: FORE-SIGHT ELITE Absolute Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 10, 2021 after 75 days
- Product code: MUD (Oximeter, Tissue Saturation)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K941811 (1994). 242 ancestors in all.
No later device cites it as a predicate yet.
1 of 243 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143675: FORE-SIGHT Elite Absolute Tissue Oximeter, Cas Medical Systems, Inc. (2015) Summary page 4.
- K201446: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module, Edwards Lifesiences, LLC (2020) Summary page 4.

## Recalls of this device
- Mar 1, 2022 · Class II · Z-0834-2022: The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in

## Indications for use
The non-invasive Fore-Sight Elite Absolute Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensor 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 ELITE Oximeter is indicated for use on adults and transitional adolescents >40 Kg. - When used with Medium Sensors, the FORE-SIGHT ELITE Oximeter is indicated for use on pediatric subjects > 3 Kg. - When used with Small Sensors, the FORE-SIGHT ELITE Oximeter is indicated for cerebral use on pediatric subjects < 8 Kg and non-cerebral use on pediatric subjects <5 Kg.

Source page: https://510kreport.com/device/K203490
Methodology: https://510kreport.com/methodology