# K100815: Oxiblue Fingertip Pulse Oximeter Model MD300C318, Oxipro Fingertip Pulse Oximeter Model MD300C316

- Pathway: 510(k) (Traditional)
- Applicant: Oxypulse
- Decided: Jun 16, 2010 after 85 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OxiBlue Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick. The OxiBlue can transmit data via either a USB cable or wireless Bluetooth technology. The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick. The OxiPro can transmit data via USB cable and does not include Bluetooth technology.

Source page: https://510kreport.com/device/K100815
Methodology: https://510kreport.com/methodology