# K073036: Fore-Sight, MC-2000 Series

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Feb 25, 2008 after 119 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: 7 generations back to K931154 (1993). 32 ancestors in all.
59 later devices descend from it; 2 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051257: Adult Cerebral Oximeter, Model 2040, Cas Medical Systems, Inc. (2005)
- K001842: Adult/Pediatric Cerebral Oximeter, Model Invos 5100, Somanetics Corp. (2000)
- K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos), Somanetics Corp. (1996) 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
- K083892: Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) (2009), 58 descendants of its own
- 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

## Indications for use
The non-invasive FORE-SIGHT Cerebral Oximeter Model MC-2000 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with FORE-SIGHT small sensors, the Cerebral Oximeter Monitor is indicated for infants and neonates 2.5Kg and above. The Cerebral Oximeter Monitor System should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the oximeter has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K073036
Methodology: https://510kreport.com/methodology