# K210770: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 29, 2021 after 136 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: 10 generations back to K001670 (2000). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183534: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2019) Summary page 4.
- K162668: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2017) Summary page 4.

## Most influential descendants
- K234041: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (2024), 1 descendant of its own
- K251113: iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor (BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor (BP-300V);iHealth Wireless Blood Pressure Monitor (BPX1);iHealth Blood Pressure Monitor (KD-595);iHealth Track Pro Connected Blood Pressure Monitor (KN-550LT);Semi Automatic Blood Pressure Monitor (KD-388N);Arm Blood Pressure Monitor (KD-553);Arm Blood Pressure Monitor (KD-557BR);Arm Blood Pressure Monitor (KD-558);Arm Blood Pr (2025), 0 descendants of its own
- K222887: Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor (2023), 0 descendants of its own
- K222869: Arm Blood Pressure Monitor (2023), 0 descendants of its own

## Indications for use
Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.

Source page: https://510kreport.com/device/K210770
Methodology: https://510kreport.com/methodology