# K033216: BZ-576 Non-Invasive Automatic Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: The Buzz Group, LLC
- Decided: May 4, 2004 after 214 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 K001670 (2000). 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)
- K001670: Automatic Blood Pressure Monitor with Intellisense, Model Hem-757, Omron Healthcare, Inc. (2000) Summary page 1.

## Indications for use
Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.

Source page: https://510kreport.com/device/K033216
Methodology: https://510kreport.com/methodology