# K051274: Invos System

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Nov 4, 2005 after 171 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: 1 generation back to K001842 (2000). 1 ancestor in all.
76 later devices descend from it; 8 cite it directly.
0 of 78 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 3.

## Most influential descendants
- K080769: Invos Cerebral/Somatic Oximeter System, Model 5100C (2008), 68 descendants of its own
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C (2009), 66 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 noninvasive INVOS 5100B is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain of an individual. It is also intended for use as an adjunct trend monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in infants, children, or adults at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the INVOS System has not been demonstrated in disease states. The INVOS System should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K051274
Methodology: https://510kreport.com/methodology