# K150268: CerOX

- Pathway: 510(k) (Traditional)
- Applicant: Or-Nim Medical, Ltd.
- Decided: Nov 6, 2015 after 275 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K931154 (1993). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131854: CEROX, Or-Nim Medical, Ltd. (2013) Summary page 4.
- K112820: Fore-Sight Absolute Tissue Oximeter, Cas Medical Systems, Inc. (2012) Summary page 4.

## Indications for use
The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx3215FOP monitor is intended for monitoring of newborn - adult. The prospective clinical value of data from the CerOx 3215FOP monitor has not been demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K150268
Methodology: https://510kreport.com/methodology