# K011779: Avidcare Series 100 Telemanagement System

- Pathway: 510(k) (Special)
- Applicant: Avid Care Corp.
- Decided: Jul 13, 2001 after 36 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
No predicates in its family tree.
91 later devices descend from it; 4 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K031840: Carematix Wellness System (2003), 90 descendants of its own
- 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

## Indications for use
The intended use for both the cleared and the modified Home Health Monitor System is for home use, patient operated: 1. non-invasive blood pressure measurement, 2. non-invasive blood oxygen saturation measurement using pulse oximetry, 3. in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood, and 4. patient weight using a stand-on electronic scale; and subsequent transmission of these measurements to a computer monitoring station in a clinical setting.

Source page: https://510kreport.com/device/K011779
Methodology: https://510kreport.com/methodology