# K100014: Fully Automatic Electronic Blood Pressure Monitor, Model KD-557

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Jan 29, 2010 after 25 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: 6 generations back to K001670 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091500: Modification to:Fully Automatic Electronic Blood Pressure Monitor, Model KD-556, Andon Health Co, Ltd. (2009) Summary page 1.

## Most influential descendants
- K111826: Fully Automatic Electronic Blood Pressure Monitor (2011), 0 descendants of its own

## Indications for use
KD-557 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/K100014
Methodology: https://510kreport.com/methodology