# K023286: Carecompanion Patient Station/Carecompanion Patient Station

- Pathway: 510(k) (Traditional)
- Applicant: Neptec Design Group, Ltd.
- Decided: May 2, 2003 after 212 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K022274: Carecompanion Patient Station & Nurse Station, Neptec Design Group, Ltd. (2003). Our reading of the summary gave K022274, which FDA decided on May 29, 2003, after this device was decided (May 2, 2003), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 2.

## Most influential descendants
- K090801: Electronic House Call (2009), 3 descendants of its own
- K102063: Health-E-Connect System (2011), 1 descendant of its own
- K163664: Health-e-Connect System with IDA (2017), 0 descendants of its own
- K093895: Ally Platform System (2010), 0 descendants of its own

## Indications for use
The Carecompanion Patient Station is intended to be used in conjunction with the Carecompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional. The Carecompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The vital signs information includes: blood pressure, pulse rate, weight, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, and heart, lung and bowel sounds. The information is collected from the Carecompanion Patient Station and transmitted over standard telephone lines to a health care professional. The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgement 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/K023286
Methodology: https://510kreport.com/methodology