# K080326: KD-391 Semi Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 31, 2008 after 176 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: 1 generation back to K052676 (2006). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K052676: KD-322 Semi Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2006) Summary page 1.

## Most influential descendants
- K190207: Blood Pressure Monitor (2019), 0 descendants of its own
- K091739: Semi Automatic Electronic Blood Pressure Monitor, Models KD-3917, KD 3909 (2009), 0 descendants of its own

## Indications for use
KD-391 Semi 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/K080326
Methodology: https://510kreport.com/methodology