# K122098: Apps-HEALTH01

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Mar 21, 2013 after 248 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102939: Fully Automatic Electronic Blood Pressure Monitor Model KD-931, Andon Health Co, Ltd. (2011) Summary page 1.

## Most influential descendants
- K132148: S Health (2013), 0 descendants of its own

## Indications for use
The Apps-HealthOl is intended for use in home settings as an aid for people to review, analyze, and evaluate test results which are measured from a blood pressure monitor or scale.

Source page: https://510kreport.com/device/K122098
Methodology: https://510kreport.com/methodology