510(k) · Cleared
ClearedAviva Systems Model Numbers 1010, 2020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Telecare, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jul 15, 1998 after a 77-day review. The FDA summary names its predicate without a number. 67 later devices descend from it.
- Decided
- Jul 15, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 3 citing it directly.
- This deviceK981533 Aviva Systems Model Numbers 1010, 2020American Telecare, Inc. · 1998
- Descendant · cites it directly · 53 of its ownK012801 N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001
- Descendant · cites it directly · 52 of its ownK020584 N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002
- Descendant · 2 generations on · 39 of its ownK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- Descendant · 3 generations on · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · 4 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K012801N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001 · cites it directly53descendants
- K020584N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002 · cites it directly52descendants
- K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003 · 2 generations on39descendants
- K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · 3 generations on34descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981533 | Aviva Systems Model Numbers 1010, 2020 | American Telecare, Inc. | 1998 | — |
| +1 | K012801 | N2000 Base Station, N2001 Nurse Station | Neptec Design Group, Ltd. | 2001 | — |
| +1 | K020584 | N2000 Base Station; N2001 Nurse Station | Neptec Design Group, Ltd. | 2002 | — |
| +2 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| +3 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +4 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | American TeleCare’s Personal Telemedicine Module Named without a submission number | |
| * | — | American TeleCare’s Digital Personal Telemedicine Module Named without a submission number | |
| * | — | American TeleCare’s Personal Telemedicine System Named without a submission number |
What descends from it? (67)
See all 673 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012801 (Neptec Design Group, Ltd., 2001) has gone furthest, with 53 descendants of its own.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981533: Aviva Systems Model Numbers 1010, 2020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981533
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026