# K021252: Blood-Pressure Meter

- Pathway: 510(k) (Traditional)
- Applicant: Idt Technology Limited
- Decided: Jun 17, 2002 after 59 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, measures automatically human’s Systolic,.Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above.

Source page: https://510kreport.com/device/K021252
Methodology: https://510kreport.com/methodology