# K180155: Arm Type Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Aug 3, 2018 after 196 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: 8 generations back to K903134 (1991). 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)
- K151869: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH, Switzerland (2015) Summary page 5.

## Indications for use
BPM64R automatically measures human’s Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being’s Arm. The intended use of this over-the-counter device is for adults aged 18 years and older with Arm circumference ranging 220 ~ 420 mm (approx. 9 ~ 17 inch) and for home use.

Source page: https://510kreport.com/device/K180155
Methodology: https://510kreport.com/methodology