# K071075: Terumo Digital Blood Pressure Monitor ES-H55A

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: May 25, 2007 after 39 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: 2 generations back to K871718 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032499: A & D Medical Lifesource UA-704 Digital Blood Pressure Monitors, A&D Engineering, Inc. (2003) Summary page 1.
- K962655: Aneroid and Mercurial Sphygmomanometers, American Diagnostic Corp. (1997) Summary page 1.

## Indications for use
The TERUMO digital blood pressure monitor ES-H55A is a non-invasive device to measure blood pressure at upper arm for pediatric(age 3 and above ) except for neonate and infant, and adult, using an appropriate sized cuff. It measures systolic and diastolic blood pressures and pulse rate using oscillometric method, also it serves as a manual sphygmomanometer using a stethoscope. It is intended for professional use.

Source page: https://510kreport.com/device/K071075
Methodology: https://510kreport.com/methodology