# K061112: Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M

- Pathway: 510(k) (Special)
- Applicant: Conmed Corporation
- Decided: May 22, 2006 after 31 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: 6 generations back to K962603 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032831: Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200, Ans-200, Ahl-200, NHL-200, Conmed Corporation (2004) Summary page 1.

## Indications for use
The PRO 2®Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2) and pulse rate. The PRO2 is intended to monitor arterial saturation on the back or forehead locations in pediatric and adult populations. The PRO 2 is for use in hospitals, hospital-type facilities and intra-hospital transport environment.

Source page: https://510kreport.com/device/K061112
Methodology: https://510kreport.com/methodology