# K090768: Fully Automatic Electronic Blood Pressure Monitor, Models KD 5901, KD-7909,

- 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). 7 ancestors in all.
5 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)
- K083317: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5902, Andon Health Co, Ltd. (2009) Summary page 1.
- K070826: KD-795 Wrist Measurement Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Most influential descendants
- K092045: Fully Automatic Electronic Blood Pressure Monitor, Models KD-738 and KD-739 (2009), 3 descendants of its own
- K110018: Fully Automatic Electronic Blood Pressure Monitor (2011), 0 descendants of its own
- K102930: Fully Automatic Electronic Blood Pressure Monitor (2010), 0 descendants of its own
- K092811: Fully Automatic Electronic Blood Pressure Monitor, Models KD-7035B, KD-7921, KD-7903 (2010), 0 descendants of its own
- K092588: Fully Automatic Electronic Blood Pressure Monitor, Model KD-5910,KD-5911, KD-5918 (2009), 0 descendants of its own

## Indications for use
KD-5901 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-7909 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/K090768
Methodology: https://510kreport.com/methodology