# K111826: Fully Automatic Electronic Blood Pressure Monitor

- Pathway: 510(k) (Special)
- Applicant: Andon Health Co, Ltd.
- Decided: Dec 9, 2011 after 164 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: 7 generations back to K001670 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100014: Fully Automatic Electronic Blood Pressure Monitor, Model KD-557, Andon Health Co, Ltd. (2010) Summary page 1.
- K101010: Fully Automatic Electronic Blood Pressure Monitor Model: KD-5963NU, KD-5008, Andon Health Co, Ltd. (2010) Summary page 1.

## Indications for use
KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J 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/K111826
Methodology: https://510kreport.com/methodology