# K102609: KD-5966 Series Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Andon Medical Co., Ltd.
- Decided: Dec 9, 2010 after 90 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: 6 generations back to K001670 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093528: Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963, Andon Health Co, Ltd. (2009) Summary page 2.
- K101010: Fully Automatic Electronic Blood Pressure Monitor Model: KD-5963NU, KD-5008, Andon Health Co, Ltd. (2010) Summary page 2.

## Indications for use
KD-5966 series 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/K102609
Methodology: https://510kreport.com/methodology