# K093923: Cerox Model 3210

- Pathway: 510(k) (Special)
- Applicant: Or-Nim Medical, Ltd.
- Decided: Jan 19, 2010 after 28 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: 8 generations back to K931154 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073407: Pacifica, Or-Nim Medical, Ltd. (2008) Summary page 1.

## Indications for use
The noninvasive Or-Nim CerOx Model 3210 monitor is intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain of an adult. It is also intended for use as an adjunct monitor of hemoglobin oxygen saturation of blood in a region of skeletal muscle tissue beneath the sensor in adults. The prospective clinical value of data from the CerOx monitor has not been demonstrated in disease states. The CerOx monitor should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K093923
Methodology: https://510kreport.com/methodology