510(k) · Cleared
Recalled · Class II · 2026Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 14, 2016 as substantially equivalent to K140339 (Covidien, 2014) and 1 other predicate after a 244-day review. Its family tree reaches back 9 generations to 1993. It has been recalled once.
- Decided
- Nov 14, 2016
- Review
- 244 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K921669 (1993). 32 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations between
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- This deviceK160718 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2016
Show all 9 generations
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 8 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 7 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 6 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 5 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 4 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- This deviceK160718 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −8 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −7 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −6 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −5 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −4 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −3 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −2 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| −1 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| 0 (this device) | K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformSummary page 4…and DSI. Primary Predicate Device: Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K140339) Secondary Predicate Device: GE Carescape Central Station (K133882)… | 2014 |
| * | K133882 | Carescape Central Station (Formally Known as Cic Pro)Summary page 4…ager & Virtual Patient Monitoring Platform (K140339) Secondary Predicate Device: GE Carescape Central Station (K133882) 1 K160718 Page 2 of 5 Device Description The subject Vita… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2026 | Class II | Z-1557-2026 | Under Investigation by firm | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 11 of the 32 ancestors have a recall of any class.
- 2 other devices also cite its predicate K140339.
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 Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS). The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data…
Read the full statement (225 words)
The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS).
The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms, alarms and alerts routed through the Vital Sync™ Informatics Manager from supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals in a hospital or hospital-type facility for the following purposes:
- To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management.
- To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.
- To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.
- To set and adjust alert thresholds on supported devices where this capability is not available on the device itself.
- To access data, waveforms and alerts from supported devices where these capabilities are not enabled or available on the device itself.
WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are notification systems and are not replacements for direct patient observation, patient assessment or clinical judgment
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/K160718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160718: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160718
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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