# K040012: Well@Home System

- Pathway: 510(k) (Traditional)
- Applicant: Zoe Medical, Inc.
- Decided: Apr 2, 2004 after 88 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864318 (1987). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952979: Hanc Network, Healthtech Services Corp. (1996) Summary page 1.
- K001775: Zoe Medical Nightingale Monitoring System, Zoe Medical, Inc. (2001) Summary page 1.
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 1.

## Most influential descendants
- K100913: Iqvitals and Iqvitals System (2010), 0 descendants of its own

## Recalls of this device
- Feb 2, 2009 · Not classified · Z-2166-2010: Touch panel may become unresponsive.

## Indications for use
The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.

Source page: https://510kreport.com/device/K040012
Methodology: https://510kreport.com/methodology