# K163113: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series

- Pathway: 510(k) (Special)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: Jan 19, 2017 after 73 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 K012310 (2001). 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)
- K142088: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series, Grandway Technology (Shenzhen) Limited (2014) Summary page 5.

## Indications for use
This device is for use by medical professional or home users. It is intended to measure the systolic and diastolic blood pressure of an adult individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist.

Source page: https://510kreport.com/device/K163113
Methodology: https://510kreport.com/methodology