# K091021: Modification to Medicompass Connect

- Pathway: 510(k) (Traditional)
- Applicant: Imetrikus, Inc.
- Decided: Jul 15, 2009 after 97 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: 13 generations back to K864318 (1987). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042768: Medicompass Connect, Imetrikus, Inc. (2005) Summary page 1.
- K073038: Carematix Wellness System, Model CWS-5000.1-B, Carematix, Inc. (2008) Summary page 1.
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 1.
- K083331: Confidant, Model 2.6, Confidant, Inc. (2009) Summary page 1.
- K080091: Modification to:Health Buddy Appliance, Health Hero Network, Inc. (2008) Summary page 1.
- K070543: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2007) Summary page 1.
- K063612: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 1.
- K060843: Modification to Health Buddy Appliance, Health Hero Network, Inc. (2006) Summary page 1.
- K050567: Health Buddy Appliance, Health Hero Network, Inc. (2005) Summary page 1.
- K042273: Modification to Health Buddy with Device Connectivity, Health Hero Network, Inc. (2004) Summary page 1.
- K040086: Health Buddy with Buddylink, Health Hero Network, Inc. (2004) Summary page 1.
- K993128: Healthbuddy with Device Connect [Glucose Meter], Health Hero Network, Inc. (1999) Summary page 1.

## Indications for use
The MediCompass® Connect serves as an interface or a gateway between personal monitoring devices and a general-purpose personal health management database. The MediCompass Connect collects physiologic measurements and retrospectively monitors vital signs from defined personal monitoring devices and transmits the data to a central database server, using standard communication technologies. MediCompass Connect is designed for professional, personal and home use. MediCompass Connect is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment.

Source page: https://510kreport.com/device/K091021
Methodology: https://510kreport.com/methodology