# K120320: Connected Care Clinical Application

- Pathway: 510(k) (Traditional)
- Applicant: Watermark Medical, Inc.
- Decided: Aug 14, 2012 after 194 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: 2 generations back to K053453 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072272: Honeywell Hommed Central Station 4.0, Honeywell Hommed, LLC (2007) Summary page 1.

## Most influential descendants
- K131203: Ihealth Cloud (2013), 0 descendants of its own

## Indications for use
Clinical Application's intended use is to retrospectively receive, display and store monitored vital Signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.

Source page: https://510kreport.com/device/K120320
Methodology: https://510kreport.com/methodology