# K141984: Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Apr 29, 2015 after 282 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: 8 generations back to K001670 (2000). 8 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2012) Summary page 4.

## Most influential descendants
- K162668: Fully Automatic Electronic Blood Pressure Monitor (2017), 5 descendants of its own
- K210770: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor (2021), 4 descendants of its own
- K192609: Globalcare Blood Pressure Monitor (2020), 3 descendants of its own
- K234041: Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) (2024), 1 descendant of its own
- K222160: GUS610 Blood pressure monitor (2022), 1 descendant of its own

## Indications for use
KD-927 and KD-928 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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/K141984
Methodology: https://510kreport.com/methodology