# K013273: Fukuda Denshi Model HG-500, Pulse Oximeter Module

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Dec 20, 2001 after 80 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 K945464 (1995). 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)
- K945464: Fukuda Denshi Mode HG-302 Pulse Oximeter Module, Fukuda Denshi USA, Inc. (1995) Summary page 1.

## Indications for use
The Fukuda Denshi model HG-500 Pulse Oximeter Module is indicated in those situations where it is desirable to perform continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate for adult, pediatric and neonatal patients who are under the care of a physician, within the confines of a health care facility. It is not intended for home use

Source page: https://510kreport.com/device/K013273
Methodology: https://510kreport.com/methodology