# K030419: Viterion 100 Telehealth Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Viterion Telehealthcare, LLC
- Decided: Nov 6, 2003 after 269 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (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). 7 ancestors in all.
88 later devices descend from it; 5 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K004050: Panasonic Tele-Homecare System, Matsushita Electric Industrial Co., Ltd. (2001)
- K952979: Hanc Network, Healthtech Services Corp. (1996) Summary page 3.

## 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

## Recalls of this device
- Nov 15, 2012 · Class II · Z-0821-2013: Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose 
- Nov 15, 2012 · Class II · Z-0820-2013: Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose 

## Indications for use
The Viterionl 00 TeleHealth Monitor is a physiological monitoring system. The system collects, accumulates, transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and practitioner. It can record physiological information such as: Blood PressurePulse Blood Hemoglobin Oxygen Saturation (SpOz) Bodyweight Blood Glucose Temperature Respiratory Peak Flow

Source page: https://510kreport.com/device/K030419
Methodology: https://510kreport.com/methodology