# K981533: Aviva Systems Model Numbers 1010, 2020

- Pathway: 510(k) (Traditional)
- Applicant: American Telecare, Inc.
- Decided: Jul 15, 1998 after 77 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.
67 later devices descend from it; 3 cite it directly.
0 of 68 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 Personal Telemedicine Module: named in the summary without a submission number
- (no number) American TeleCare’s Digital Personal Telemedicine Module: named in the summary without a submission number
- (no number) American TeleCare’s Personal Telemedicine System: named in the summary without a submission number

## Most influential descendants
- K012801: N2000 Base Station, N2001 Nurse Station (2001), 53 descendants of its own
- 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

## Indications for use
The PIM Systems are intended for use as a monitoring device, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient’s heart and lung sounds.

Source page: https://510kreport.com/device/K981533
Methodology: https://510kreport.com/methodology