# K112820: Fore-Sight Absolute Tissue Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Jan 26, 2012 after 120 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: 11 generations back to K931154 (1993). 46 ancestors in all.
47 later devices descend from it; 4 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)
- K094030: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030, Cas Medical Systems, Inc. (2010) Summary page 1.
- K091224: Oxyalert Nirsensors, Accessories for Invos 5100C System, Models: IS-C and IS-S, Somanetics Corp. (2009) Summary page 1.
- (no number) FORE-SIGHT predicate: named in the summary without a submission number

## Most influential descendants
- K133879: Fore-Sight Elite Absolute Tissue Oximeter (2014), 44 descendants of its own
- 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

## Indications for use
The non-invasive FORE-SIGHT® 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 the brain of adults and children over 40 Kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of small adults and children between 4 and 80 Kg, and for use on skeletal muscle of infants, children and adolescents between 4 and 50 Kg. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates less than 8 Kg, and for use on the abdomen in neonates less than 4 Kg. The prospective clinical value of data from the FORE-SIGHT Oximeter has not been demonstrated in disease states and these data should not be used as a sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K112820
Methodology: https://510kreport.com/methodology