# K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Mar 19, 2009 after 80 days
- Product code: DQA (Oximeter)
- 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: 8 generations back to K931154 (1993). 36 ancestors in all.
58 later devices descend from it; 1 cites it directly.
0 of 95 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.
- 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.
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303, Spectros Corporation (2004) Summary page 2.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 2.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 2.
- K031330: Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of Sensors and Cables, Masimo Corp. (2003) Summary page 2.

## Most influential descendants
- K091452: Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) (2009), 57 descendants of its own
- 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

## 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. The FORE-SIGHT should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the FORE-SIGHT has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K083892
Methodology: https://510kreport.com/methodology