# K071415: Digital Pulse Oximeter, Model 7500FO

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Aug 8, 2007 after 79 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: 1 generation back to K910001 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910001: Model 8604-FO Pulse Oximeter, Nonin Medical, Inc. (1991) Summary page 1.

## Indications for use
The Nonin® Model 7500FO Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

Source page: https://510kreport.com/device/K071415
Methodology: https://510kreport.com/methodology