# K242193: Arm Type Blood Pressure Monitor  (BPM82)

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Oct 22, 2024 after 88 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 K112825 (2012). 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)
- K112825: Avita Arm Type Blood Pressure Monitor, Avita Corporation (2012) Summary page 5.

## Indications for use
The product automatically measures human being’s Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The measurement results are displayed on the LCD. Measurement position is at human being’s upper arm. The intended use of this over-the-counter device is for adults with upper arm circumference ranging from 150 mm to 520 mm (Approx.6 ~ 21 inches) and for home use. When the device detects the appearance of irregular heartbeats during measurement, an indicated symbol will appear with measuring readings. This device is designed only for adults.

Source page: https://510kreport.com/device/K242193
Methodology: https://510kreport.com/methodology