# K032831: Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200, Ans-200, Ahl-200, NHL-200

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Aug 31, 2004 after 355 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: 5 generations back to K962603 (1997). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012706: IM2001 Pulse Oximeter, Imagyn Medical Technologies, Inc. (2003) Summary page 2.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K061112: Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M (2006), 0 descendants of its own

## 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 (SPO2) and pulse rate (PR). The PRO 2 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/K032831
Methodology: https://510kreport.com/methodology