510(k) · Cleared
ClearedRemotenurse Patient Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Webvmc, LLC · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jun 28, 2004 as substantially equivalent to K030222 (American Telecare, Inc., 2003) and 1 other predicate after a 42-day review. Its family tree reaches back 5 generations to 1991. 34 later devices descend from it.
- Decided
- Jun 28, 2004
- Review
- 42 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K910772 (1991). 20 ancestors in all, the oldest K893221 (1990). 34 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 4 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- This deviceK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- Descendant · cites it directly · 25 of its ownK080798 Intel Health Guide, Model: PHS6000Intel Corp. · 2008
- Descendant · 2 generations on · 12 of its ownK083862 Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK083115 Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008
- Descendant · 2 generations on · 11 of its ownK101178 Modification to Intel Health Guide PHS6000Intel Corp. · 2010
- Descendant · 2 generations on · 10 of its ownK103276 Intel Health GuideIntel Corporation Digital Health Group · 2011
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K080798Intel Health Guide, Model: PHS6000Intel Corp. · 2008 · cites it directly25descendants
- K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc. · 2009 · 2 generations on12descendants
- K083115Modification to Intel Health Guide, Model PHS6000Intel Corp. · 2008 · 2 generations on12descendants
- K101178Modification to Intel Health Guide PHS6000Intel Corp. · 2010 · 2 generations on11descendants
- K103276Intel Health GuideIntel Corporation Digital Health Group · 2011 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −4 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| 0 (this device) | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| +1 | K080798 | Intel Health Guide, Model: PHS6000 | Intel Corp. | 2008 | — |
| +2 | K083862 | Medapps 2.0 Remote Patient Monitoring System | Medapps, Inc. | 2009 | — |
| +2 | K083115 | Modification to Intel Health Guide, Model PHS6000 | Intel Corp. | 2008 | — |
| +2 | K101178 | Modification to Intel Health Guide PHS6000 | Intel Corp. | 2010 | — |
| +2 | K103276 | Intel Health Guide | Intel Corporation Digital Health Group | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K030222 | NX SystemSummary page 1…nt Monitoring System 9-Device Classification Name: Remote Patient Monitoring System 1O-Substantial Equivalency is claimed against the following devices: 1- K030222 by American Telecare, Inc 2- K022274 by Neptec Design Group Ltd 11-Description of the Device: The device "RemoteNurseM Pa… | 2003 |
| * | K022274 | Carecompanion Patient Station & Nurse StationSummary page 1…on Name: Remote Patient Monitoring System 1O-Substantial Equivalency is claimed against the following devices: 1- K030222 by American Telecare, Inc 2- K022274 by Neptec Design Group Ltd 11-Description of the Device: The device "RemoteNurseM Patient Monitoring system' is a monitoring too… | 2003 |
What descends from it? (34)
See all 343 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 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K080798 (Intel Corp., 2008) has gone furthest, with 25 descendants of its own.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The device "RemoteNurseTM Patient Monitoring system' is a monitoring tool prescribed by a licensed physician when time-critical care Is not required, and is indicated for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for…
Read the full statement (187 words)
The device "RemoteNurseTM Patient Monitoring system' is a monitoring tool prescribed by a licensed physician when time-critical care Is not required, and is indicated for use to provide caregivers remote access to vital sign measurements of patients at home, as captured on commercially available medical devices designed for home use, and transmitted to a database retrieved from a secure website. It is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data.
The device is contraindicated for patients with uncompensated heart failure, patients at high risk of life threatening arrhythmias, patients with recent myocardial infarctions, or patients requiring direct medical supervision or emergency intervention. The device is intended for patients who are willing and capable to self-administrate it.
Clinical judgment and experience are required to check and interpret the information delivered.
Typical devices that may be connected to RemoteNurseTM Patient Station are: Blood Pressure Monitor, Glucose Meter, Weight Scale, Pulse-oxidation, Peak Flow, ECG and PT/INR. Also, digital camera may be connected to RemoteNuseym Patient Station. The unit supports up to 8 devices in the same time.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041308: Remotenurse Patient Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041308
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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