# K062724: Accupulse Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Eagle Medical Equipment Co.
- Decided: May 11, 2007 after 241 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 K051736 (2005). 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)
- K051736: Fox Pulse Oximeter, Shunsuke Nakanishi (2005) Summary page 1.

## Indications for use
The Finger Pulse Oximeter is a small portable device that measures % SPO2, pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.

Source page: https://510kreport.com/device/K062724
Methodology: https://510kreport.com/methodology