# K151258: Arm automatic blood pressure monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Pump Medical System Co., Ltd.
- Decided: Feb 18, 2016 after 282 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 K052153 (2005). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130325: Arm Automatic Blood Pressure Monitor, Shenzhen Pump Medical System Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K161712: Arm automatic blood pressure monitor (2017), 0 descendants of its own
- K161708: Arm automatic blood pressure monitor (2016), 0 descendants of its own

## 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: 22c¢m to 44cm (8.7in to 17.3in)) is wrapped around the single upper arm.

Source page: https://510kreport.com/device/K151258
Methodology: https://510kreport.com/methodology