# K131854: CEROX

- Pathway: 510(k) (Special)
- Applicant: Or-Nim Medical, Ltd.
- Decided: Sep 13, 2013 after 84 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 3210F: named in the summary without a submission number

## Most influential descendants
- K150268: CerOX (2015), 0 descendants of its own

## Indications for use
The non-invasive CerOx 3215F0 monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx 3215F0 monitor is intended for monitoring of adults. The prospective clinical value of data from the CerOx 3215F0 monitor has not been demonstrated in disease states. The CerOx 3215F0 monitor should not be used as the sole basis for diagnosis or therapy.

Source page: https://510kreport.com/device/K131854
Methodology: https://510kreport.com/methodology