# K240729: Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Medical Electronics Co., Ltd.
- Decided: Jun 14, 2024 after 88 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 5.

## 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. The intended arm circumference includes 22 cm~32 cm.

Source page: https://510kreport.com/device/K240729
Methodology: https://510kreport.com/methodology