# K210435: Automatic Arm Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.
- Decided: May 12, 2021 after 89 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: 7 generations back to K001670 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183058: Arm-type Electronic Blood Pressure Monitor, Shenzhen Bsx Technology Electronics Co., Ltd. (2019) Summary page 4.

## Indications for use
The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.

Source page: https://510kreport.com/device/K210435
Methodology: https://510kreport.com/methodology