# K183058: Arm-type Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bsx Technology Electronics Co., Ltd.
- Decided: Jul 3, 2019 after 243 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.
3 later devices descend from it; 3 cite it directly.
0 of 10 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 4.

## Most influential descendants
- K211532: Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 (2022), 0 descendants of its own
- K210435: Automatic Arm Electronic Blood Pressure Monitor (2021), 0 descendants of its own
- K193387: Arm Electronic Sphygmomanometer (2021), 0 descendants of its own

## Indications for use
The blood pressure monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the arm of which the circumference includes 22 cm~32 cm. It is intended to be used in hospital environment or at home.

Source page: https://510kreport.com/device/K183058
Methodology: https://510kreport.com/methodology