510(k) · Cleared
ClearedVital Sync Model 5000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somanetics Corp. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Apr 29, 2010 as substantially equivalent to K033283 (Icu Datasystems, Inc., 2003) after a 177-day review. Its family tree reaches back 1 generation to 2003. 19 later devices descend from it.
- Decided
- Apr 29, 2010
- Review
- 177 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033283 (2003). 19 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK033283 Centra View Device Link SystemIcu Datasystems, Inc. · 2003
- This deviceK093422 Vital Sync Model 5000 SeriesSomanetics Corp. · 2010
- 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 |
|---|---|---|---|---|---|
| −1 | K033283 | Centra View Device Link System | Icu Datasystems, Inc. | 2003 | — |
| 0 (this device) | K093422 | Vital Sync Model 5000 Series | Somanetics Corp. | 2010 | — |
| +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 | — |
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 |
|---|---|---|---|
| * | K033283 | Centra View Device Link SystemSummary page 1…Vice President, Medical Affairs 248-244-1449 Predicate Device:....................... CentraView, ICU DataSystems, K033283 Device Description: .................... The Vital SynCTM System is a bedside data… | 2003 |
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?
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. 2010, 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'TM System is intended for 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.
Vital Sync System displayed parameters are listed on the following pages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093422: Vital Sync Model 5000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093422
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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