# K083078: Quanta Blood Pressure Meter, Model: Cardiac Elite 1000 or QH200

- Pathway: 510(k) (Traditional)
- Applicant: Quanta Computer, Inc.
- Decided: Nov 26, 2008 after 41 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 K982481 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052154: Omron Automatic Blood Pressure Monitor, Model Hem-711AC, Omron Healthcare, Inc. (2005) Summary page 1.
- K982481: A&D Medical UA-767PC Digital Blood Pressure Monitor, A&D Engineering, Inc. (1998) Summary page 1.

## Indications for use
The Quanta Blood Pressure Meter, Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.

Source page: https://510kreport.com/device/K083078
Methodology: https://510kreport.com/methodology