# K012801: N2000 Base Station, N2001 Nurse Station

- Pathway: 510(k) (Traditional)
- Applicant: Neptec Design Group, Ltd.
- Decided: Nov 14, 2001 after 85 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
Longest line of descent: 1 generation back to K981533 (1998). 2 ancestors in all.
53 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000237: Ehc 400 Desktop Patient Station, Ehc 600 Core Provider Station, Cybercare, Inc. (2000) Summary page 2.
- K981533: Aviva Systems Model Numbers 1010, 2020, American Telecare, Inc. (1998) Summary page 2.

## Most influential descendants
- K020584: N2000 Base Station; N2001 Nurse Station (2002), 52 descendants of its own
- K022274: Carecompanion Patient Station & Nurse Station (2003), 39 descendants of its own
- K041308: Remotenurse Patient Monitoring System (2004), 34 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own

## Indications for use
The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional. The N2000 Base Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the N2000 Base Station and transmitted over standard telephone lines to a health care professional. The device does not send any real-time alarms. The device is not indicated for diagnostic purposes. 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/K012801
Methodology: https://510kreport.com/methodology