# K223291: Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Medical Electronics Co., Ltd.
- Decided: Jun 14, 2023 after 231 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 K001671 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161845: Electronic Blood Pressure Monitor, Shenzhen Pango Electronic Co., Ltd. (2017) Summary page 6.

## Most influential descendants
- K232815: Wrist Blood Pressure Monitor (2023), 0 descendants of its own

## 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 wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm. The patient population does not include adolescents aged 12 to <18 years of age. The patient population includes transition adolescent B (18 to < 22 years of age but treated like adult) and adults (at least 22 years of age).

Source page: https://510kreport.com/device/K223291
Methodology: https://510kreport.com/methodology