# K093387: Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962, KD-5902

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Nov 27, 2009 after 28 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: 5 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)
- K083246: Fully Automated Electronic Blood Pressure Monitor, Model KD-5961, Andon Health Co, Ltd. (2009) Summary page 1.
- K090771: Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962, Andon Health Co, Ltd. (2009) Summary page 1.
- K083317: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902, Andon Health Co, Ltd. (2009) Summary page 1.

## Indications for use
KD-5961,KD-5962,KD-5902 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/K093387
Methodology: https://510kreport.com/methodology