# K250116: Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
- Decided: Apr 24, 2025 after 98 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: 9 generations back to K001670 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222125: Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G, Shenzhen AOJ Medical Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.

Source page: https://510kreport.com/device/K250116
Methodology: https://510kreport.com/methodology