# K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Aug 21, 2009 after 95 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: 9 generations back to K931154 (1993). 38 ancestors in all.
57 later devices descend from it; 2 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040, Cas Medical Systems, Inc. (2006) Summary page 2.
- K073036: Fore-Sight, MC-2000 Series, Cas Medical Systems, Inc. (2008) Summary page 2.
- K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030), Cas Medical Systems, Inc. (2009) Summary page 2.
- K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100, Somanetics Corp. (2000) Summary page 2.
- K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos), Somanetics Corp. (1996) Summary page 2.
- K051274: Invos System, Somanetics Corp. (2005) Summary page 2.
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C, Somanetics Corp. (2008) Summary page 2.
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 2.
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303, Spectros Corporation (2004) Summary page 2.

## Most influential descendants
- K094030: Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030 (2010), 53 descendants of its own
- K102715: Regional Oximeter (2010), 53 descendants of its own
- 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

## Indications for use
The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. When used with FORE-SIGHT large sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with the FORE-SIGHT medium sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter is indicated for use with small adults and children between 4 kg and 80 kg. When used with FORE-SIGHT small sensors the FORE-SIGHT MC-2000 Series Cerebral Oximeter Monitor is indicated for infants and neonates < 8Kg.

Source page: https://510kreport.com/device/K091452
Methodology: https://510kreport.com/methodology