# K120554: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Wrist-Type Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Aug 10, 2012 after 169 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: 5 generations back to K982481 (1998). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111686: A & D Medical UA-1000 Family Dagital Blood Pressure Monitors, A&D Company, Ltd. (2011) Summary page 5.

## Most influential descendants
- K161577: Arm-Type Fully Automatic Digital Blood Pressure Monitor (2017), 0 descendants of its own
- K150545: Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) (2015), 0 descendants of its own
- K130232: Electronic Blood Pressure Monitor for Upper Arm (2013), 0 descendants of its own

## Indications for use
Measure blood pressure (systolic and diastolic) and pulse rate.

Source page: https://510kreport.com/device/K120554
Methodology: https://510kreport.com/methodology