510(k) · Cleared
Recalled · Class II · 2014Vital 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 Dec 4, 2013 as substantially equivalent to K130796 (Covidien, 2013) after a 106-day review. Its family tree reaches back 2 generations to 2012. 24 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 4, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K122133 (2012). 24 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK122133 Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 2012
- 1 generation backK130796 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013 · Recalled
- This deviceK132604 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2013
- Descendant · cites it directly · 22 of its ownK140339 Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · Recalled
- Descendant · cites it directly · 18 of its ownK142732 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 2 generations on · 17 of its ownK151715 T3 SoftwareEtiometry, Inc. · 2015
- Descendant · 2 generations on · 16 of its ownK152258 T3 SoftwareEtiometry, Inc. · 2016
- Descendant · 3 generations on · 15 of its ownK163065 T3 SoftwareEtiometry, Inc. · 2017
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K140339Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien · 2014 · cites it directly22descendants
- K142732T3 SoftwareEtiometry, Inc. · 2015 · cites it directly18descendants
- K151715T3 SoftwareEtiometry, Inc. · 2015 · 2 generations on17descendants
- K152258T3 SoftwareEtiometry, Inc. · 2016 · 2 generations on16descendants
- K163065T3 SoftwareEtiometry, Inc. · 2017 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing | Airstrip Technologies, LP | 2012 | — |
| −1 | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | 2 |
| 0 (this device) | K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2013 | — |
| +1 | K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Covidien | 2014 | 2 |
| +1 | K142732 | T3 Software | Etiometry, Inc. | 2015 | — |
| +2 | K151715 | T3 Software | Etiometry, Inc. | 2015 | — |
| +2 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| +3 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformSummary page 1…MWI. OUG Predicate Device: Vital SyncTm Informatics Manager & Virtual Patient Monitoring Platform (K130796) Page lofl4… | 2013 |
What descends from it? (24)
See all 243 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2014 | Class II | Z-2235-2014 | Software design | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system. |
| Jul 17, 2014 | Class II | Z-2234-2014 | Software design | Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140339 (Covidien, 2014) has gone furthest, with 22 descendants of its own.
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. 2013, 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 Electronic Medical Record (eMR) and Clinical Information System (CIS). The Vital Sync Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync Informatics Manager for supported devices. The Vital…
Read the full statement (171 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 Electronic Medical Record (eMR) and Clinical Information System (CIS).
The Vital Sync Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync Informatics Manager for supported devices. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:
- To remotely consult regarding a patient's status
- To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
WARNING: The Vital Sync Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132604: 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 6, 2026. https://510kreport.com/device/K132604
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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