# K141683: Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Urion Technology Co., Ltd.
- Decided: Apr 3, 2015 after 284 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
Longest line of descent: 3 generations back to K001671 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 5.

## Indications for use
U60 Series Wrist Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.

Source page: https://510kreport.com/device/K141683
Methodology: https://510kreport.com/methodology