# K120673: Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series

- Pathway: 510(k) (Traditional)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: Feb 14, 2013 after 346 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: 3 generations back to K012310 (2001). 3 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K110299: Digital Automatic Wrist Blood Pressure Monitor WBPM10 Series, Grandway Technology (Shenzhen) Limited (2011) Summary page 3.

## Most influential descendants
- K133618: Digital Automatic Wrist Blood Pressure Monitor WBPM22 Series (2014), 5 descendants of its own
- K142088: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (2014), 2 descendants of its own
- K143733: Digital Automatic Wrist Blood Pressure Monitor MD2400 (2015), 1 descendant of its own
- K171379: Digital Automatic Wrist Blood Pressure Monitor MD4300 (2018), 0 descendants of its own
- K163113: Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series (2017), 0 descendants of its own

## Indications for use
Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series is for use by medical professional or at home. The WBPM15 Series is intended to measure the systolic and diastolic blood pressure, and pulse rate (heartbeat rate) of an individual by using a non-invasive technique, in which an inflatable cuff is wrapped around the wrist of an individual. The inflatable cuff circumference is limited to 13.5cm - 19.5cm.

Source page: https://510kreport.com/device/K120673
Methodology: https://510kreport.com/methodology