# K160563: Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Health Co, Ltd.
- Decided: Aug 4, 2016 after 157 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: 7 generations back to K001671 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111830: Fully Automatic Electronic Blood Pressure Monitor Model KD-7902BTJ, Fully Automatic Electronic Blood Pressure Monitor MO, Andon Health Co, Ltd. (2011) Summary page 4.

## Indications for use
KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are 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/K160563
Methodology: https://510kreport.com/methodology