# K053419: Konica Minolta Pulsox-300, 300I

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Sensing, Inc.
- Decided: May 11, 2006 after 154 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: 2 generations back to K863918 (1987). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984570: Minolta Pulsox-3/Minolta Pulsox-3I, In-X Corp. (2000) Summary page 1.
- K010413: Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI, Konica Minolta Sensing, Inc. (2001) Summary page 1.

## Most influential descendants
- K113865: Pultol (2012), 0 descendants of its own
- K090438: Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor (2009), 0 descendants of its own

## Indications for use
The Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO 2 ) and pulse rate from light signals of two wavelengths transmitted through tissues of adult patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.

Source page: https://510kreport.com/device/K053419
Methodology: https://510kreport.com/methodology