# K984570: Minolta Pulsox-3/Minolta Pulsox-3I

- Pathway: 510(k) (Traditional)
- Applicant: In-X Corp.
- Decided: Aug 30, 2000 after 616 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 K863918 (1987). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863918: Minolta/Marquest Pulsox-7 Oxygen Saturation Monit., Marquest Medical Products, Inc. (1987) Summary page 1.

## Most influential descendants
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device (2004), 5 descendants of its own
- K053419: Konica Minolta Pulsox-300, 300I (2006), 2 descendants of its own
- K202483: MyHomeDoc (2021), 1 descendant of its own
- K170181: Prizma (2017), 1 descendant of its own
- K223785: N9+ (2023), 0 descendants of its own

## Indications for use
The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO.) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study.

Source page: https://510kreport.com/device/K984570
Methodology: https://510kreport.com/methodology