# K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Oct 28, 2005 after 269 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: 3 generations back to K872291 (1987). 12 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032305: Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907XL, Omron Healthcare, Inc. (2004) Summary page 1.
- K013434: VP-2000/1000, Colin Corp. (2002) Summary page 1.
- K012487: Sphygmocor PX Model Scor-PX, Atcor Medical Pty, Ltd. (2002) Summary page 1.

## Most influential descendants
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (2007), 4 descendants of its own
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (2010), 2 descendants of its own
- K131916: Bprosoft Casp PC Software (2014), 0 descendants of its own
- K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software (2014), 0 descendants of its own
- K121266: Cardioscope (2012), 0 descendants of its own

## Indications for use
The HEM-9000AI 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 measure/calculate radial augmentation index (Al). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated. The augmentation index (Al) function of the HEM-9000A1 has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).

Source page: https://510kreport.com/device/K050233
Methodology: https://510kreport.com/methodology