# K051736: Fox Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shunsuke Nakanishi
- Decided: Dec 2, 2005 after 157 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K031371: Saphyre Bipolar Ablation Probes, Smith & Nephew, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K062724: Accupulse Pulse Oximeter (2007), 0 descendants of its own

## Indications for use
The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital, or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults. This device is not intended for continous patient monitoring. There are no audible or visible patient alarms

Source page: https://510kreport.com/device/K051736
Methodology: https://510kreport.com/methodology