# K182242: VO200 – NeurOs Cerebral Oximetry System

- Pathway: 510(k) (Traditional)
- Applicant: Mespere Lifesciences, Inc.
- Decided: Dec 26, 2018 after 128 days
- Product code: QEM (Cerebral 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: 4 generations back to K001842 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082327: Invos Cerebral/Somatic Oximeter System, Model: 5100C, Somanetics Corp. (2009) Summary page 4.

## Indications for use
The VO200 – NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K182242
Methodology: https://510kreport.com/methodology