# K004050: Panasonic Tele-Homecare System

- Pathway: 510(k) (Traditional)
- Applicant: Matsushita Electric Industrial Co., Ltd.
- Decided: Mar 15, 2001 after 76 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
89 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030419: Viterion 100 Telehealth Monitor (2003), 88 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

## Recalls of this device
- Nov 15, 2012 · Class II · Z-0822-2013: 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 

Source page: https://510kreport.com/device/K004050
Methodology: https://510kreport.com/methodology