# K162144: iHealth Wireless Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Health Co, Ltd.
- Decided: Feb 1, 2017 after 184 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.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141984: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2015) Summary page 4.
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2012) Summary page 4.
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931, Andon Health Co, Ltd. (2011) Summary page 5.

## Most influential descendants
- K221742: Conneqt Pulse (2023), 0 descendants of its own

## Indications for use
The BPM1 (Electronic Sphygmomanometer) is intended for use in a professional setting or at home and is a non-invasive blood pressure measurement system. It is designed to measure the systolic and diastolic blood pressures and pulse rate of an adult individual by using a technique in which an inflatable cuff is wrapped around the upper arm. The measurement range of the cuff circumference is 8.6” to18.9” (22cm-48cm)

Source page: https://510kreport.com/device/K162144
Methodology: https://510kreport.com/methodology