# K200716: Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Electronic Co., Ltd.
- Decided: Dec 4, 2020 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
Longest line of descent: 6 generations back to K001670 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170151: Electronic Blood Pressure Monitor, Shenzhen Pango Electronic Co., Ltd. (2017) Summary page 6.

## Indications for use
The 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 upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm~32 cm and 32 cm~42 cm.

Source page: https://510kreport.com/device/K200716
Methodology: https://510kreport.com/methodology