# K220106: QardioArm 2

- Pathway: 510(k) (Traditional)
- Applicant: Qardio, Inc.
- Decided: Jun 15, 2022 after 154 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140067: Qardioarm, Qardio, Inc. (2014) Summary page 4.

## Indications for use
The QardioArm 2 is a fully automatic, non-invasive, wireless blood pressure monitor intended to measure the systolic and diastolic blood pressures and pulse rate of adult individuals. It utilizes an inflatable cuff that is wrapped around the upper arm. The arm circumference is limited to 8.7 - 18.5 inches (22 - 47 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. It is not intended to be used as a diagnostic device and users are instructed to contact their physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K220106
Methodology: https://510kreport.com/methodology