# K193387: Arm Electronic Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changkun Technology Co., Ltd.
- Decided: Jan 27, 2021 after 418 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
Arm Electronic Sphygmomanometer 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/K193387
Methodology: https://510kreport.com/methodology