# K081654: HEM-9000AI

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Oct 10, 2008 after 120 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: 5 generations back to K950779 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI, Omron Healthcare, Inc. (2005) Summary page 1.
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.
- K070795: Sphygmocor Cardiovascular Management System, Atcor Medical Pty, Ltd. (2007) Summary page 1.

## Indications for use
The HEM-9000Ai-X is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 17 - 50 cm (7-20 inches), and to calculate a radial augmentation index (Al) and central (aortic) blood pressure which is used on adult patients only. The HEM-9000AI-X is intended for use in physicians' offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial Al measurements/calculations are performed on patients and invasive measurement is contraindicated. The Augmentation Index (Al) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).

Source page: https://510kreport.com/device/K081654
Methodology: https://510kreport.com/methodology