# K131021: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Nonin Medical, Inc.
- Decided: Sep 11, 2013 after 152 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: 8 generations back to K910772 (1991). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112843: Pulse Oximeter, Nonin Medical, Inc. (2012) Summary page 1.
- K081285: Finger Pulse Oximeter, Model 9560, Nonin Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K191403: Pulse Oximeter (2019), 1 descendant of its own
- K202743: Med-Link Temp-pulse Oximeter (2021), 0 descendants of its own
- K140785: Pulse Oximeter (2014), 0 descendants of its own

## Indications for use
The Model 3230 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 Isintended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 Inch (0.8 -2.5 cm) thick.

Source page: https://510kreport.com/device/K131021
Methodology: https://510kreport.com/methodology