# K043018: Omron Digital Blood Pressure Monitor, Model Hem-906

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 10, 2004 after 8 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 device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 8 inches to 13 inches (20 cm - 33 cm).

Source page: https://510kreport.com/device/K043018
Methodology: https://510kreport.com/methodology