# K080319: KD-591 Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 2, 2008 after 147 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: 3 generations back to K001670 (2000). 3 ancestors in all.
51 later devices descend from it; 4 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070828: KD-595 Fully Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Most influential descendants
- K090963: Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 (2009), 46 descendants of its own
- K101950: Fully Automatic Electronic Blood Pressure Monitor Model KD-930 (2010), 34 descendants of its own
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931 (2011), 33 descendants of its own
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor (2012), 27 descendants of its own
- K141984: Fully Automatic Electronic Blood Pressure Monitor (2015), 13 descendants of its own

## Indications for use
KD-591 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/K080319
Methodology: https://510kreport.com/methodology