# K160349: Electronic Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Nov 3, 2016 after 269 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: 5 generations back to K001670 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131558: PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6, Shenzhen Pango Electronic Co., Ltd. (2013) Summary page 5.

## Indications for use
The device is intended to measure diastolic, systolic blood pressure and the pulse rate of an adult patient via non-invasive technique in which an inflatable cuff is wrapped around the upper arm. It is intended to be used at home. The intended arm circumference is 17cm~22cm, 22cm~32cm, 32cm~42cm.

Source page: https://510kreport.com/device/K160349
Methodology: https://510kreport.com/methodology