# K130325: Arm Automatic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pump Medical System Co., Ltd.
- Decided: Dec 24, 2013 after 319 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 K052153 (2005). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121932: Hem-7200-Z (BP742), Omron Healthcare, Inc. (2012) Summary page 1.

## Most influential descendants
- K151258: Arm automatic blood pressure monitor (2016), 2 descendants of its own
- K161712: Arm automatic blood pressure monitor (2017), 0 descendants of its own
- K161708: Arm automatic blood pressure monitor (2016), 0 descendants of its own
- K153033: Digital Blood Pressure Monitor (2016), 0 descendants of its own

## Indications for use
It is intended for measuring adult blood pressure and pulse rate.

Source page: https://510kreport.com/device/K130325
Methodology: https://510kreport.com/methodology