# K121372: Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Sep 10, 2012 after 126 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 K001670 (2000). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102906: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2010) Summary page 1.
- K110330: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2011) Summary page 2.

## Most influential descendants
- K160565: Fully Automatic Electronic Blood Pressure Monitor (2016), 0 descendants of its own
- K151460: Fully Automatic Electronic Blood Pressure Monitor (2015), 0 descendants of its own
- K140121: Fully Automatic Electronic Blood Pressure Monitor (2014), 0 descendants of its own

## Indications for use
KD-513LU and KD-513LC 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-4Scm.

Source page: https://510kreport.com/device/K121372
Methodology: https://510kreport.com/methodology