# K110156: Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Jul 27, 2011 after 189 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 K983575 (1999). 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)
- K091068: Accutorr V Monitor, Model 0998-00-2000, Datascope Corp., Patient Monitoring Division (2009) Summary page 2.

## Indications for use
ABPM50 Automatic Blood Pressure Monitor is intended to monitor the systolic, diastolic and mean blood pressure as well as pulse rate via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used on adult, pediatric and neonatal individuals.

Source page: https://510kreport.com/device/K110156
Methodology: https://510kreport.com/methodology