510(k) · Cleared
ClearedAMC Health VitalCaregiving System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amc Health · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 9, 2016 as substantially equivalent to K051544 (Advanced Monitoring Caregiving, Inc., 2005) and 1 other predicate after a 431-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Sep 9, 2016
- Review
- 431 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910772 (1991). 33 ancestors in all, the oldest K893221 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK022274 Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
- 2 generations backK041308 Remotenurse Patient Monitoring SystemWebvmc, LLC · 2004
- 1 generation backK051544 Vitalcaregiving SystemAdvanced Monitoring Caregiving, Inc. · 2005
- This deviceK151839 AMC Health VitalCaregiving SystemAmc Health · 2016
- Descendant · cites it directly · 0 of its ownK233446 AMC Health CareConsoleAmc Health · 2024
Most influential descendants
Showing 1 of 1 · See all- K233446AMC Health CareConsoleAmc Health · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K022274 | Carecompanion Patient Station & Nurse Station | Neptec Design Group, Ltd. | 2003 | — |
| −2 | K041308 | Remotenurse Patient Monitoring System | Webvmc, LLC | 2004 | — |
| −1 | K051544 | Vitalcaregiving System | Advanced Monitoring Caregiving, Inc. | 2005 | — |
| 0 (this device) | K151839 | AMC Health VitalCaregiving System | Amc Health | 2016 | — |
| +1 | K233446 | AMC Health CareConsole | Amc Health | 2024 | — |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K051544 | Vitalcaregiving SystemSummary page 5…irStrip RPM Epiphany AMC Health VitalCaregiving System I Adapter VitalCaregiving System II 510(k) Number K051544 K133450 FDA Classification Transmitters And Receivers, Monitor, Physiological, Transmit… | 2005 |
| * | K133450 | Airstrip Remote Patient MonitoringSummary page 5…h VitalCaregiving System I Adapter VitalCaregiving System II 510(k) Number K051544 K133450 FDA Classification Transmitters And Receivers, Monitor, Physiological, Transmitters And Electr… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233446 | AMC Health CareConsole | 2024 | 0 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 33 ancestors have a recall of any class.
- Of its descendants, K233446 (Amc Health, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K051544.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The AMC Health VitalCaregiving System II (“VitalCaregiving System II”) is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which…
Read the full statement (186 words)
The AMC Health VitalCaregiving System II (“VitalCaregiving System II”) is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition.
• Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices.
• The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging.
The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151839: AMC Health 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/K151839
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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