# K093528: Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Dec 4, 2009 after 18 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). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090771: Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962, Andon Health Co, Ltd. (2009) Summary page 1.
- K091997: Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962, Andon Health Co, Ltd. (2009) Summary page 1.

## Most influential descendants
- K102609: KD-5966 Series Fully Automatic Electronic Blood Pressure Monitor (2010), 0 descendants of its own
- K100940: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5965 (2010), 0 descendants of its own

## Indications for use
KD-5963 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. KD-7963 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 wrist. The cuff circumference is limited to 14cm-25cm.

Source page: https://510kreport.com/device/K093528
Methodology: https://510kreport.com/methodology