# K241393: ODI-Tech

- Pathway: 510(k) (Traditional)
- Applicant: Odi Medical AS
- Decided: Aug 30, 2024 after 106 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The noninvasive ODI-Tech, when used with the DRS handpiece, is intended for use as an adjunct monitor of local hemoglobin oxygen saturation of blood in the skin beneath the sensor on the dorsum of the hand. It is intended as an adjunct for assessing local perfusion in individuals at risk of reduced-flow or no-flow ischemic states. The device is indicated for use on intact skin only. The clinical value of trend data has not been demonstrated in disease states. The ODI-Tech device should not be used as the sole basis for diagnosis or therapy. In patients with darkly pigmented skin, measurements should be interpreted with caution, as melanin can interfere with the reflected light signal and reduce the quality of measurements.

Source page: https://510kreport.com/device/K241393
Methodology: https://510kreport.com/methodology