# K161577: Arm-Type Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Feb 8, 2017 after 246 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)
- K120554: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic Digital Blood Pressure Monitor, Sejoy Electronics & Instruments Co., Ltd. (2012) Summary page 5.

## Indications for use
Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

Source page: https://510kreport.com/device/K161577
Methodology: https://510kreport.com/methodology