510(k) · Cleared
ClearedVital Sync System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, Formerly Nellcor Puritan Bennett, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 27, 2013 as substantially equivalent to K093244 (Geratherm Medical AG, 2010) after a 153-day review. Its family tree reaches back 4 generations to 2000. 19 later devices descend from it.
- Decided
- Feb 27, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991684 (2000). 5 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK991684 Chillbuster Portable Electric Blanket System, Model 8001Thermogear, Inc. · 2000
- 3 generations backK022903 ChillbusterMicrotek Medical, Inc. · 2002
- 2 generations backK052392 Hot Dog Patient Warming SystemAugustine Biomedical & Design, LLC · 2006
- 1 generation backK093244 Unique Temp Warming Blankets, Model 8001140XXXGeratherm Medical AG · 2010
- This deviceK123002 Vital Sync SystemCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2013
- 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
- Descendant · 4 generations on · 14 of its ownK190273 T3 Platform softwareEtiometry, Inc. · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- 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
- K190273T3 Platform softwareEtiometry, Inc. · 2019 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991684 | Chillbuster Portable Electric Blanket System, Model 8001 | Thermogear, Inc. | 2000 | — |
| −3 | K022903 | Chillbuster | Microtek Medical, Inc. | 2002 | — |
| −2 | K052392 | Hot Dog Patient Warming System | Augustine Biomedical & Design, LLC | 2006 | — |
| −1 | K093244 | Unique Temp Warming Blankets, Model 8001140XXX | Geratherm Medical AG | 2010 | — |
| 0 (this device) | K123002 | Vital Sync System | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013 | — |
| +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 | — |
| +4 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K093244 | Unique Temp Warming Blankets, Model 8001140XXXSummary page 1…arrhythmia detection or alarms) Cardiovascular A.3. Predicate Device: Vital SyncTm System (K093244) A.4. Device Description The Vital SyncTM System is being extended to offer additional device compatibility and parame… | 2010 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142732 | T3 Software | 2015 | 18 |
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 5 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K142732 (Etiometry, Inc., 2015) has gone furthest, with 18 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™ System is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.
The Vital Sync™ System displayed parameters are listed on the following pages.
WARNING: The Vital Sync™ System is not an active patient monitoring system. It is intended to supplement and not to replace any part of the hospital's device monitoring.
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/K123002 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123002: Vital Sync System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123002
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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