# K140785: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Jul 7, 2014 after 98 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: 9 generations back to K910772 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131021: Pulse Oximeter, Nonin Medical, Inc. (2013) Summary page 1.

## Indications for use
The NaninO Model 3231 Finger Pulse Oximeter isa small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients with digits between 0.8 -2.5 cm (0.3 -1.0 inch) thick.

Source page: https://510kreport.com/device/K140785
Methodology: https://510kreport.com/methodology