# K080289: 1500 PRO

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Feb 26, 2008 after 22 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: 1 generation back to K061822 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.

## 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 9 to 17 inches (22-42 cm) via an "arm in" cuff. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guidelines of 135/85 mm Hg. The Omron 150OPro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. It is intended as an OTC device for home use.

Source page: https://510kreport.com/device/K080289
Methodology: https://510kreport.com/methodology