# K010413: Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Sensing, Inc.
- Decided: Aug 2, 2001 after 171 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053419: Konica Minolta Pulsox-300, 300I (2006), 2 descendants of its own
- K033711: Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System (2004), 1 descendant of its own
- K113865: Pultol (2012), 0 descendants of its own
- K103134: Fukuda Denshi (2011), 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

## Recalls of this device
- Nov 14, 2003 · Not classified · Z-0290-04: Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
- Nov 14, 2003 · Not classified · Z-0289-04: Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.

Source page: https://510kreport.com/device/K010413
Methodology: https://510kreport.com/methodology