# K120675: Digital Automatic Blood Pressure Monitor BPM11 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: 2 generations back to K001670 (2000). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033397: Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY, Avita Corporation (2004) Summary page 1.

## Most influential descendants
- K133619: Digital Automatic Blood Pressure Monitor BPM18 Series (2014), 8 descendants of its own
- 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

## Indications for use
Digital Automatic Blood Pressure Monitor BPM1 1 Series is for use by medical professional or at home. The BPM1 1 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 upper arm of an individual. The inflatable cuff circumference is limited to 17cm- 44cm via 3 different size of cuff. 3 different cuff sizes are 17-22cm, 22-32cm and 32-44cm.

Source page: https://510kreport.com/device/K120675
Methodology: https://510kreport.com/methodology