# K971628: Somanetics Invos 3100A Cerebral Oximeter (Invos)

- Pathway: 510(k) (Traditional)
- Applicant: Somanetics Corp.
- Decided: Oct 10, 1997 after 161 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: 2 generations back to K863784 (1986). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960614: Somanetics Invos 3100A Cerebral Oximeter (Invos), Somanetics Corp. (1996) Summary page 1.

## Most influential descendants
- K111007: Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest RE (2011), 0 descendants of its own
- K100523: Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM, HHS-SPFB-Usa (2010), 0 descendants of its own

## Indications for use
The noninvasive INVOS 3100A Cerebral Oximeter is intended for use 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/K971628
Methodology: https://510kreport.com/methodology