# K121355: Wrist-Type Fully Automatic Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Jul 18, 2012 after 75 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: 3 generations back to K002115 (2000). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042967: A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512, A&D Engineering, Inc. (2004) Summary page 2.

## Most influential descendants
- K170666: The Wrist-Type Fully Automatic Digital Blood Pressure Monitors (2017), 0 descendants of its own
- K152426: Wrist - Type Fully Automatic Digital Blood Pressure Monitor (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K121355
Methodology: https://510kreport.com/methodology