510(k) · Cleared
ClearedVitalcaregiving System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Monitoring Caregiving, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 7, 2005 as substantially equivalent to K041854 (Aerotel Medical Systems, Ltd., 2004) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 7, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K910772 (1991). 31 ancestors in all, the oldest K893221 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 1 generation backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- This deviceK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK063008 Health Check KioskXperex Corporation · 2007
- Descendant · cites it directly · 1 of its ownK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- Descendant · 2 generations on · 1 of its ownK101198 Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK233446 AMC Health CareConsoleAmc Health · 2024
- Descendant · 3 generations on · 0 of its ownK153600 Consult Station TSH4D Sas · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K063008Health Check KioskXperex Corporation · 2007 · cites it directly4descendants
- K151839AMC Health VitalCaregiving SystemAmc Health · 2016 · cites it directly1descendant
- K101198Csi Managed Health System Model: Csi Model 9KComputerized Screening, Inc. · 2010 · 2 generations on1descendant
- K233446AMC Health CareConsoleAmc Health · 2024 · cites it directly0descendants
- K153600Consult Station TSH4D Sas · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −5 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −1 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| 0 (this device) | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| +1 | K063008 | Health Check Kiosk | Xperex Corporation | 2007 | — |
| +1 | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| +2 | K101198 | Csi Managed Health System Model: Csi Model 9K | Computerized Screening, Inc. | 2010 | — |
| +1 | K233446 | AMC Health CareConsole | Amc Health | 2024 | — |
| +3 | K153600 | Consult Station TS | H4D Sas | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K041854 | MPM SystemSummary page 1…Classification name: Telephone Electrocardiographic transmitter and receiver (870.2920/74DXH) 3. Equivalent legally- marketed devices: Aerotel MPM, K041854 RemoteNurse, K041308 Cybemet Medstar K020534 AMC 510(k) Summary Page A2… | 2004 |
| * | K041308 | Remotenurse Patient Monitoring SystemSummary page 1…one Electrocardiographic transmitter and receiver (870.2920/74DXH) 3. Equivalent legally- marketed devices: Aerotel MPM, K041854 RemoteNurse, K041308 Cybemet Medstar K020534 AMC 510(k) Summary Page A2 4. Description T… | 2004 |
| * | K020534 | Medstar System, Models 533-300Summary page 1…ter and receiver (870.2920/74DXH) 3. Equivalent legally- marketed devices: Aerotel MPM, K041854 RemoteNurse, K041308 Cybemet Medstar K020534 AMC 510(k) Summary Page A2 4. Description The AMC System receives data from… | 2003 |
What descends from it? (7)
3 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 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K063008 (Xperex Corporation, 2007) has gone furthest, with 4 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 AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home patients via home monitoring devices connected via wired or wireless facilities to a central station, where reports can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051544: Vitalcaregiving System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051544
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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