# K102631: KD-931D Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Nov 4, 2010 after 52 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). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090963: Fully Automatic Electronic Blood Pressure Monitor, Model KD-556, Andon Health Co, Ltd. (2009) Summary page 1.

## Most influential descendants
- K110872: Withings Blood Pressure Monitor (2011), 3 descendants of its own
- K133125: Withings Blood Presure Monitor (2014), 2 descendants of its own
- K182401: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology (IRT) Thermometer probe, B.O.L.T Pulse Oximeter (SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (2019), 0 descendants of its own
- K171668: Bluetooth blood pressure monitor (2018), 0 descendants of its own

## Indications for use
KD-931D 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/K102631
Methodology: https://510kreport.com/methodology