510(k) · Cleared
ClearedCarecompanion Patient Station/Carecompanion Patient 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 2, 2003 after a 212-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 1 citing it directly.
- This deviceK023286 Carecompanion Patient Station/Carecompanion Patient StationNeptec Design Group, Ltd. · 2003
- Descendant · cites it directly · 3 of its ownK090801 Electronic House CallExpress MD Solutions, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK102063 Health-E-Connect SystemAlr Technologies · 2011
- Descendant · 3 generations on · 0 of its ownK163664 Health-e-Connect System with IDAAlr Technologies · 2017
- Descendant · 2 generations on · 0 of its ownK093895 Ally Platform SystemContinuity Health Solutions · 2010
Most influential descendants
Showing 4 of 4 · See all- K090801Electronic House CallExpress MD Solutions, LLC · 2009 · cites it directly3descendants
- K102063Health-E-Connect SystemAlr Technologies · 2011 · 2 generations on1descendant
- K163664Health-e-Connect System with IDAAlr Technologies · 2017 · 3 generations on0descendants
- K093895Ally Platform SystemContinuity Health Solutions · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023286 | Carecompanion Patient Station/Carecompanion Patient Station | Neptec Design Group, Ltd. | 2003 | — |
| +1 | K090801 | Electronic House Call | Express MD Solutions, LLC | 2009 | — |
| +2 | K102063 | Health-E-Connect System | Alr Technologies | 2011 | — |
| +3 | K163664 | Health-e-Connect System with IDA | Alr Technologies | 2017 | — |
| +2 | K093895 | Ally Platform System | Continuity Health Solutions | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 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? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K022274 | FDA’s K022274 is Carecompanion Patient Station & Nurse Station Our reading of the summary gave K022274, which FDA decided on May 29, 2003, after this device was decided (May 2, 2003), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 2…companion, modified with the addition of the peak flow meter, ECG, breathalyzer and auxiliary camera, is substantially equivalent to the predicate Neptec Carecompanion (#K022274) that has previously been approved by the FDA. The modified Carecompanion and its predicate have the same general use: to allow… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090801 | Electronic House Call | 2009 | 3 |
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, K090801 (Express MD Solutions, LLC, 2009) has gone furthest, with 3 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 vital signs information includes: blood pressure, pulse…
Read the full statement (159 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 vital signs information includes: blood pressure, pulse rate, weight, blood glucose level, blood oxygen saturation level, blood alcohol level, pulmonary function parameters, cardiac function parameters, and heart, lung and bowel sounds. 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 is a diagnostic 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 as stated in the FDA summary.
https://510kreport.com/device/K023286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023286: Carecompanion Patient Station/Carecompanion Patient Station.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023286
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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