# K161712: Arm automatic blood pressure monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Pump Medical System Co., Ltd.
- Decided: Apr 5, 2017 after 288 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: 4 generations back to K052153 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151258: Arm automatic blood pressure monitor, Shenzhen Pump Medical System Co., Ltd. (2016) Summary page 4.

## Indications for use
It is a device intended to measure the systolic, diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff (available sizes: 22cm~44cm (8.7in~17.3in)) is wrapped around the single upper arm.

Source page: https://510kreport.com/device/K161712
Methodology: https://510kreport.com/methodology