# K131203: Ihealth Cloud

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 19, 2013 after 81 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: 3 generations back to K053453 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120320: Connected Care Clinical Application, Watermark Medical, Inc. (2012) Summary page 1.

## Indications for use
Ihealth cloud's intended use is to retrospectively display and analyze related medical data. The Web Application is not intended for emergency use or real-time monitoring.

Source page: https://510kreport.com/device/K131203
Methodology: https://510kreport.com/methodology