# K031863: Carestation 126S Videophone

- Pathway: 510(k) (Traditional)
- Applicant: Motion Media Technology, Inc.
- Decided: Oct 10, 2003 after 116 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981533 (1998). 6 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020584: N2000 Base Station; N2001 Nurse Station, Neptec Design Group, Ltd. (2002) Summary page 2.
- K963678: Caretone II, American Telecare, Inc. (1997) Summary page 2.
- K001308: Modification to Zymed Telemetry System, Model Easiview, Agilent Technologies (2000) Summary page 2.

## Most influential descendants
- K052608: Telephone Based BL Healthcare Remote Care Management System (RCMS) (2006), 5 descendants of its own
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own
- K073710: Intouch Remote Presence Robotic System, Model RP-7 (2008), 2 descendants of its own
- K131739: Nxstage Connected Health System (2013), 1 descendant of its own
- K120895: Remote Presence System (2012), 1 descendant of its own

## Indications for use
The Carestation CS 126s is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider’s site. The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse rate, blood pressure, temperature, blood glucose, weight, and breath peak flow measurements. The information is collected upon the request and direction of the health care provider. The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgment and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Source page: https://510kreport.com/device/K031863
Methodology: https://510kreport.com/methodology