# K030222: NX System

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Aug 19, 2003 after 209 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) American TeleCare’s Aviva 200 System: named in the summary without a submission number

## Most influential descendants
- 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
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 descendants of its own
- K101178: Modification to Intel Health Guide PHS6000 (2010), 11 descendants of its own

## Indications for use
The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PTANR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.

Source page: https://510kreport.com/device/K030222
Methodology: https://510kreport.com/methodology