# K091738: Semi Automatic Electronic Blood Pressure Monitor, Model KD-388BD

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Aug 18, 2009 after 68 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: 4 generations back to K001670 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083395: Semi-Fully Automatic Electronic Blood Pressure Monitor, Models: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598, Andon Health Co, Ltd. (2009) Summary page 1.

## Indications for use
KD-388BD 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/K091738
Methodology: https://510kreport.com/methodology