# K134029: Belter Blood Pressure Meter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Belter Health Measurement and Analysis TE
- Decided: Jul 25, 2014 after 206 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: 2 generations back to K052153 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121932: Hem-7200-Z (BP742), Omron Healthcare, Inc. (2012) Summary page 1.

## Indications for use
Belter Blood pressure meter Is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home. The device detects the appearance of Irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K134029
Methodology: https://510kreport.com/methodology