# K980824: A&D UB-322 Watch Style Wrist Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: A&D Engineering, Inc.
- Decided: Mar 19, 1998 after 15 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.

Source page: https://510kreport.com/device/K980824
Methodology: https://510kreport.com/methodology