# K012706: IM2001 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Imagyn Medical Technologies, Inc.
- Decided: Mar 7, 2003 after 570 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 K962603 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.

## Most influential descendants
- K032831: Pro 2 Monitor, Pro 2 Sensor, PRO2 Holder, PRO2 Neonate Holder, Models, Pro- 200, Ans-200, Ahl-200, NHL-200 (2004), 1 descendant of its own
- K061112: Conmed PRO2 Pulse Reflectance Oximeter, Model Pro-M (2006), 0 descendants of its own

## Indications for use
The IM2001 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. For use with pediatric and adult population, in hospitals, hospital-type facilities and intra-hospital transport environment. For prescription use only.

Source page: https://510kreport.com/device/K012706
Methodology: https://510kreport.com/methodology