# K031840: Carematix Wellness System

- Pathway: 510(k) (Traditional)
- Applicant: Carematix, Inc.
- Decided: Oct 10, 2003 after 116 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: 5 generations back to K864318 (1987). 14 ancestors in all.
90 later devices descend from it; 4 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B), Philips Medical Systems (2002)
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A, Hewlett-Packard Co. (1999) Summary page 1.
- K011779: Avidcare Series 100 Telemanagement System, Avid Care Corp. (2001)
- K010029: Home Health Monitoring System, Avid Care Corp. (2001)

## Most influential descendants
- K040966: Modification to Carematix Wellness System (2004), 86 descendants of its own
- K050929: The Hermes System (2005), 45 descendants of its own
- K042273: Modification to Health Buddy with Device Connectivity (2004), 45 descendants of its own
- K050567: Health Buddy Appliance (2005), 40 descendants of its own
- K060843: Modification to Health Buddy Appliance (2006), 39 descendants of its own

## Indications for use
The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; Measurement of blood glucose; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient’s home setting. Prescription Device. Federal law (US) restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K031840
Methodology: https://510kreport.com/methodology