# K094030: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Dec 23, 2010 after 358 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: 10 generations back to K931154 (1993). 44 ancestors in all.
53 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030), Cas Medical Systems, Inc. (2009) Summary page 3.
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 3.
- K100915: Inspectra STO2 Tissue Oxygenation Monitor, Model 650, Hutchinson Technology, Inc. (2010). Cleared while this submission was under review Summary page 3.
- K081233: T-Stat 303 Ischemia Monitoring System, Spectros Corporation (2008) Summary page 3.

## Most influential descendants
- K112820: Fore-Sight Absolute Tissue Oximeter (2012), 47 descendants of its own
- K133879: Fore-Sight Elite Absolute Tissue Oximeter (2014), 44 descendants of its own
- K113215: Model 7600 Regional Oximeter System with Equanox Technology (2012), 42 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

## Indications for use
The FORE-SIGHT® Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain and skeletal muscle. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. 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. When used with Small sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of infants and neonates ≤ 8 kg. When used with Medium sensors, the FORE-SIGHT Oximeter is indicated for use on skeletal muscle of infants, children and adolescents between 5 and 50 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/K094030
Methodology: https://510kreport.com/methodology