# K100875: Cerox, Model 321OF

- Pathway: 510(k) (Traditional)
- Applicant: Or-Nim Medical, Ltd.
- Decided: Jan 25, 2011 after 301 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CerOx 3210: named in the summary without a submission number
- (no number) Laserflo Blood Perfusion Monitor BPM 2: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K100875
Methodology: https://510kreport.com/methodology