# K131245: Oregon Scintific

- Pathway: 510(k) (Traditional)
- Applicant: Idt Technology Limited
- Decided: Jan 17, 2014 after 261 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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
By using oscillometric method, the device measure automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. This device is intended for use on adults for age 18 and above. The cuff size is fit for arm circumference of 22-32 cm. The device has the irregular heartbeat indicator feature. The color bar gives a warning signal with readings. The BPU321I can be compatible with the device of Bluetootli Smart-enabled. All values will be read out in LCD panel.

Source page: https://510kreport.com/device/K131245
Methodology: https://510kreport.com/methodology