# K110775: Electronic Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: May 13, 2011 after 53 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: 8 generations back to K903134 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093013: Blood Pressure Monitor, Model MD200A, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 2.

## Indications for use
CONTEC08C Electronic Sphygmomanometer is intended to measure 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 individuals.

Source page: https://510kreport.com/device/K110775
Methodology: https://510kreport.com/methodology