# K102624: Avita Wrist Type Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Dec 16, 2010 after 94 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200346: Wrist Type Blood Pressure Monitor (2020), 0 descendants of its own

## Indications for use
The AViTA 8PM lx Series device automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the wrist. The device is intended to be used by adults with a wrist circumference ranging from 125 mm to 210 mm (approx. 4.9 -~8.3 inches). The device is intended for home use. When the device detects irregular heartbeats during measurement, an irregular heartbeat symbol will appear along with the measured readings.

Source page: https://510kreport.com/device/K102624
Methodology: https://510kreport.com/methodology