# K121470: Fully Automatic Wireless Blood Pressure Wrist Monitor

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Jun 14, 2012 after 28 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: 1 generation back to K102906 (2010). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102906: Fully Automatic Electronic Blood Pressure Monitor, Andon Health Co, Ltd. (2010) Summary page 1.

## Most influential descendants
- K152379: iHealth View BP7S Wireless Blood Pressure Wrist Monitor (2015), 2 descendants of its own
- K163276: Fully Automatic Electronic Blood Pressure Monitor (2017), 1 descendant of its own
- K210768: Wrist Blood Pressure Monitor, Blood Pressure Monitor (2021), 0 descendants of its own

## Indications for use
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 13.5cm-22cm.

Source page: https://510kreport.com/device/K121470
Methodology: https://510kreport.com/methodology