# K090769: Fully Automatic Electronic Blood Pressure Monitor, Model KD-7961

- 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: 3 generations back to K001671 (2000). 3 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Most influential descendants
- K091997: Fully Automatic Electronic Blood Pressure Monitor, Model KD-7962 (2009), 7 descendants of its own
- K093452: Fully Automatic Electronic Blood Pressure Monitor Model KD-571, KD-7971 (2009), 2 descendants of its own
- K093528: Fully Automatic Electronic Blood Pressure Monitor Model KD-5963, KD-7963 (2009), 2 descendants of its own
- K111830: Fully Automatic Electronic Blood Pressure Monitor Model KD-7902BTJ, Fully Automatic Electronic Blood Pressure Monitor MO (2011), 1 descendant of its own
- K160563: Fully Automatic Electronic Blood Pressure Monitor (2016), 0 descendants of its own

## Indications for use
KD-7961' 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 6.1023 inches to 9.8425 inches.

Source page: https://510kreport.com/device/K090769
Methodology: https://510kreport.com/methodology