# K090771: Fully Automatic Electronc Blood Pressure Monitor, Model, KD-5962

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Jun 4, 2009 after 73 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). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083317: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902, Andon Health Co, Ltd. (2009) Summary page 3.

## Most influential descendants
- K093528: Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963 (2009), 2 descendants of its own
- 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
- K093387: Fully Automatic Electronic Blood Pressure Monitor Model KD-5961, KD-5962, KD-5902 (2009), 0 descendants of its own

## Indications for use
KD-5962 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/K090771
Methodology: https://510kreport.com/methodology