# K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos)

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Jun 5, 1996 after 113 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: 1 generation back to K863784 (1986). 2 ancestors in all.
67 later devices descend from it; 8 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.
- K884329: Sat-2 Oximeter/Cardiac Output Computer, Baxter Healthcare Corp (1988) Summary page 1.

## Most influential descendants
- K051257: Adult Cerebral Oximeter, Model 2040 (2005), 63 descendants of its own
- 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

## Indications for use
The noninvasive INVOS 3100A Cerebral Oximeter should be used in adults as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood in the brain of an individual. Because INVOS values are relative within an individual, the INVOS should not be used as the sole basis for decisions as to diagnosis or therapy. The value of data from the INVOS has not been demonstrated in disease states.

Source page: https://510kreport.com/device/K960614
Methodology: https://510kreport.com/methodology