# K250765: AViTA Arm Type Blood Pressure Monitor Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Avita Corporation
- Decided: Sep 3, 2025 after 174 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K790810 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231961: NIBPCuff, Shenzhen Sino-K Medical Technology Co.,Ltd (2023) Summary page 5.

## Indications for use
The cuff is compatible with non-invasive blood pressure monitors to measure blood pressure. It is intended for use by healthcare professionals (prescription use) and by laypersons in home settings (over-the-counter use). The cuff is designed for adult patients. It is non-sterile and reusable.

Source page: https://510kreport.com/device/K250765
Methodology: https://510kreport.com/methodology