# K051257: Adult Cerebral Oximeter, Model 2040

- Pathway: 510(k) (Traditional)
- Applicant: Cas Medical Systems, Inc.
- Decided: Dec 22, 2005 after 220 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: 6 generations back to K931154 (1993). 25 ancestors in all.
63 later devices descend from it; 3 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K040684: T-Stat Microvascular Tissue Oximeter, Model 303, Spectros Corporation (2004) Summary page 2.
- K042501: Etg-4000 Optical Topography System, Hitachi Medical Corp. (2004) Summary page 2.
- K011320: Etg-100 Optical Encephalography System, Hitachi Medical Systems America, Inc. (2001) Summary page 2.

## Most influential descendants
- K073036: Fore-Sight, MC-2000 Series (2008), 59 descendants of its own
- K061960: Fore-Sight Cerebral Oximeter Monitor, Model 2040 (2006), 59 descendants of its own
- 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

## Indications for use
The non-invasive Adult Cerebral Oximeter Model 2040 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. 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 Cerebral Oximeter Monitoring System has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K051257
Methodology: https://510kreport.com/methodology