# K140067: Qardioarm

- Pathway: 510(k) (Traditional)
- Applicant: Qardio, Inc.
- Decided: Jun 18, 2014 after 159 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: 8 generations back to K001670 (2000). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2012) Summary page 3.
- K121025: YA Horng Blood Pressure Monitor, YA Horng Blood Pressure Monitor, Bluetooth Transmission, Ya Horng Electronic Co., Ltd. (2012) Summary page 3.

## Most influential descendants
- K150430: Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor (2015), 6 descendants of its own
- K171833: Digital Blood Pressure Monitor-Wrist Style (2018), 4 descendants of its own
- K220651: Wrist Type Blood Pressure Monitor (2022), 2 descendants of its own
- K230409: Wrist Type Blood Pressure Monitor (W05,W1101L) (2023), 1 descendant of its own
- K253570: Blood Pressure Monitor (W06LT) (2026), 0 descendants of its own

## Indications for use
QardioArm, model A100 is a fully automatic, non-invasive, wireless blood pressure monitor. QardioArm, model A100 is a blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. QardioArm, model A100 utilizes an inflatable cuff that is wrapped around the upper arm. This device is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. The cuff circumference is limited to 22cm-37cm (8.7in -14.6in).

Source page: https://510kreport.com/device/K140067
Methodology: https://510kreport.com/methodology