# K092045: Fully Automatic Electronic Blood Pressure Monitor, Models KD-738 and KD-739

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 30, 2009 after 24 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). 8 ancestors in all.
3 later devices descend from it; 3 cite 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)
- K090768: Fully Automatic Electronic Blood Pressure Monitor, Models KD 5901, KD-7909,, Andon Health Co, Ltd. (2009) Summary page 1.

## Most influential descendants
- 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

## Indications for use
KD-738 and KD-739 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/K092045
Methodology: https://510kreport.com/methodology