# K033397: Avita BPM6 Series Blood Pressure Meter (or Monitor), Model BPM6XY

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Apr 9, 2004 after 168 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.
12 later devices descend from it; 2 cite it directly.
0 of 14 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)

## Most influential descendants
- K120675: Digital Automatic Blood Pressure Monitor BPM11 Series (2013), 10 descendants of its own
- K133619: Digital Automatic Blood Pressure Monitor BPM18 Series (2014), 8 descendants of its own
- K143735: Digital Automatic Blood Pressure Monitor MD2300 (2015), 3 descendants of its own
- K163679: Digital Automatic Blood Pressure Monitor MD3600 (2017), 1 descendant of its own
- K150373: Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] (2015), 1 descendant of its own

## Indications for use
The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.

Source page: https://510kreport.com/device/K033397
Methodology: https://510kreport.com/methodology