# K081033: Miroxi

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Jan 15, 2009 after 279 days
- Product code: DQA (Oximeter)
- 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: 4 generations back to K943404 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061712: Spirobank II, Mir Medical Intl. Research Srl (2006) Summary page 1.

## Indications for use
The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages. It can be used in any setting.

Source page: https://510kreport.com/device/K081033
Methodology: https://510kreport.com/methodology