# K222887: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Famidoc Technology Company Limited
- Decided: Apr 10, 2023 after 199 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: 11 generations back to K001670 (2000). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210770: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2021) Summary page 4.

## Indications for use
Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure is intended to measure the blood pressure and pulse rate of adults and children at least 12 years of age, at household or medical center. with the cuff around the left upper arm according to the instruction in the user's guide manual(Cuff size 220 ~ 420 mm).

Source page: https://510kreport.com/device/K222887
Methodology: https://510kreport.com/methodology