# K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device

- Pathway: 510(k) (Traditional)
- Applicant: S.P.O. Medical Equipment, Ltd.
- Decided: Sep 10, 2004 after 228 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: 4 generations back to K962603 (1997). 13 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500, Nonin Medical, Inc. (2000)
- K984570: Minolta Pulsox-3/Minolta Pulsox-3I, In-X Corp. (2000) Summary page 7.
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE, Masimo Corp. (1999) Summary page 7.
- K030668: Model 3100 Wristox Pulse Oximeter, Nonin Medical, Inc. (2003) Summary page 7.

## Most influential descendants
- K202483: MyHomeDoc (2021), 1 descendant of its own
- K170181: Prizma (2017), 1 descendant of its own
- K223785: N9+ (2023), 0 descendants of its own
- K173589: Prizma (2018), 0 descendants of its own
- K080375: RMX Physiological Data Recorder (2008), 0 descendants of its own

## Indications for use
The SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment. The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.

Source page: https://510kreport.com/device/K040178
Methodology: https://510kreport.com/methodology