# K120325: Connected Care Mobile Application

- Pathway: 510(k) (Traditional)
- Applicant: Watermark Medical
- Decided: Jul 18, 2012 after 167 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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 K040799 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101242: Genesis DM Model: 6053000A1, Honeywell Hommed, LLC (2010) Summary page 1.

## Indications for use
Mobile Application allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

Source page: https://510kreport.com/device/K120325
Methodology: https://510kreport.com/methodology