# K133619: Digital Automatic Blood Pressure Monitor BPM18 Series

- Pathway: 510(k) (Traditional)
- Applicant: Grandway Technology (Shenzhen) Limited
- Decided: Mar 5, 2014 after 100 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 K001670 (2000). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120675: Digital Automatic Blood Pressure Monitor BPM11 Series, Grandway Technology (Shenzhen) Limited (2013) Summary page 3.

## Most influential descendants
- K143735: Digital Automatic Blood Pressure Monitor MD2300 (2015), 3 descendants of its own
- K163679: Digital Automatic Blood Pressure Monitor MD3600 (2017), 1 descendant of its own
- K150373: Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] (2015), 1 descendant of its own
- K191593: Digital Automatic Blood Pressure Monitor MD36 Series (2019), 0 descendants of its own
- K163648: Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series (2017), 0 descendants of its own

## Indications for use
Digital Automatic Blood Pressure Monitor BPMES Series is for use by medival protessionis! or home user, The BPMIS Scries is intended 10 measure the systalic and dinstolic boad pressure, snd pulse mte o an sdult indisidual by aving a nos-invasive wehnique, in which an inflatable cafY is wtupped aronnd the upper ann.

Source page: https://510kreport.com/device/K133619
Methodology: https://510kreport.com/methodology