# K141416: Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pump Medical System Co., Ltd.
- Decided: Oct 9, 2014 after 133 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 K042505 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123498: BP652N (Hem-6300-Z), Omron Healthcare, Inc. (2013) Summary page 5.

## Indications for use
It is intended for measuring adult blood pressure and pulse rate with circumference ranging from 135 mm to 215 mm.

Source page: https://510kreport.com/device/K141416
Methodology: https://510kreport.com/methodology