510(k) · Cleared
ClearedN2000 Base Station; N2001 Nurse Station
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neptec Design Group, Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on May 22, 2002 as substantially equivalent to K012801 (Neptec Design Group, Ltd., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1998. 52 later devices descend from it.
- Decided
- May 22, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K981533 (1998). 3 ancestors in all. 52 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK981533 Aviva Systems Model Numbers 1010, 2020American Telecare, Inc. · 1998
- 1 generation backK012801 N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001
- This deviceK020584 N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002
- Descendant · cites it directly · 39 of its ownK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- Descendant · 2 generations on · 34 of its ownK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · 3 generations on · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 4 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 4 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003 · cites it directly39descendants
- K041308Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004 · 2 generations on34descendants
- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · 3 generations on25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 4 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981533 | Aviva Systems Model Numbers 1010, 2020 | American Telecare, Inc. | 1998 | — |
| −1 | K012801 | N2000 Base Station, N2001 Nurse Station | Neptec Design Group, Ltd. | 2001 | — |
| 0 (this device) | K020584 | N2000 Base Station; N2001 Nurse Station | Neptec Design Group, Ltd. | 2002 | — |
| +1 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| +2 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +3 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +4 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +4 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K012801 | N2000 Base Station, N2001 Nurse StationSummary page 2…ctions. Substantial Equivalence The Neptec CareCompanion is substantially equivalent to the following predicate systems: the N2000 Base Station / N2001 Nurse Station (#K012801) by Neptec Design Group Ltd, the Electronic HouseCall System (#K000237) by Cybercare, Inc., and the Aviva Systems (#K981533) by A… | 2001 |
| * | K000237 | Ehc 400 Desktop Patient Station, Ehc 600 Core Provider StationSummary page 2…ally equivalent to the following predicate systems: the N2000 Base Station / N2001 Nurse Station (#K012801) by Neptec Design Group Ltd, the Electronic HouseCall System (#K000237) by Cybercare, Inc., and the Aviva Systems (#K981533) by American Telecare, Inc. The CareCompanion and its predicate systems hav… | 2000 |
| * | K981533 | Aviva Systems Model Numbers 1010, 2020Summary page 2…he N2000 Base Station / N2001 Nurse Station (#K012801) by Neptec Design Group Ltd, the Electronic HouseCall System (#K000237) by Cybercare, Inc., and the Aviva Systems (#K981533) by American Telecare, Inc. The CareCompanion and its predicate systems have the same general use to provide the capability for… | 1998 |
What descends from it? (52)
See all 523 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K022274 (Neptec Design Group, Ltd., 2003) has gone furthest, with 39 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
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 information is collected from the CareCompanion Patient…
Read the full statement (125 words)
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 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 a 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.
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/K020584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020584: N2000 Base Station; N2001 Nurse Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020584
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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