# K993316: Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device

- Pathway: 510(k) (Traditional)
- Applicant: Ueda Avancer Corp.
- Decided: Jun 9, 2000 after 249 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 Ueda Udex Super BP-2000 Automatic Blood Pressure Recording Device is designed to provide signals from which systolic and diastolic pressures can be derived based on the ausculatory blood pressure measuring method proposed by Korotkoff. The device also measures pulse rate. This device is for use by adult population (18 years and older.) This is a non-invasive electronic sphygmomanometer.

Source page: https://510kreport.com/device/K993316
Methodology: https://510kreport.com/methodology