# K183535: Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jun 4, 2019 after 167 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: 2 generations back to K102906 (2010). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162915: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2017) Summary page 4.

## Most influential descendants
- K210768: Wrist Blood Pressure Monitor, Blood Pressure Monitor (2021), 0 descendants of its own

## Indications for use
KD-753, KD-738BR, KD-733 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 wrist. The cuff circumference is limited to 14cm-25cm.

Source page: https://510kreport.com/device/K183535
Methodology: https://510kreport.com/methodology