# K141924: HD Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Asia Corporation, Ltd.
- Decided: Sep 8, 2014 after 54 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: 6 generations back to K982481 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100658: U-Right TD-3127 Blood Pressure Monitoring System, Taidoc Technology Corporation (2010) Summary page 5.

## Indications for use
HD 3161 Blood Pressure Monitor is intended to be used to measure the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to be 9.44 to 16.9 inches (24cmࠥ43cm).

Source page: https://510kreport.com/device/K141924
Methodology: https://510kreport.com/methodology