510(k) · Cleared
Recalled · 2006Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · DYG Catheter, Flow Directed
Cleared on May 6, 1997 as substantially equivalent to K924452 (Baxter Healthcare Corp, 1993) and 1 other predicate after a 497-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- May 6, 1997
- Review
- 497 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924452 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924452 Swan-Ganz Cco/SVO2 Thermodilution CatheterBaxter Healthcare Corp · 1993 · Recalled
- This deviceK955816 Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) MonitorBaxter Healthcare Corp · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924452 | Swan-Ganz Cco/SVO2 Thermodilution Catheter | Baxter Healthcare Corp | 1993 | 2 |
| 0 (this device) | K955816 | Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor | Baxter Healthcare Corp | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 DYG? 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 DYG device
- #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 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 |
|---|---|---|---|
| * | K924452 | Swan-Ganz Cco/SVO2 Thermodilution CatheterSummary page 1…dentification The Vigilance CCO/SvO2 Monitor is substantially equivalent to the Vigilance CCO/SvO2 Monitor which was cleared for marketing under premarket notifications K924452 and K940795. Compliance with 513/514 No performance standards have been established under Section 514 of the Food, Drug and Cos… | 1993 |
| * | K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterSummary page 1…n The Vigilance CCO/SvO2 Monitor is substantially equivalent to the Vigilance CCO/SvO2 Monitor which was cleared for marketing under premarket notifications K924452 and K940795. Compliance with 513/514 No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act.… | 1994 |
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 |
|---|---|---|---|---|
| Jun 21, 2006 | Not classified | Z-1310-06 | Other | Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYG
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DYG
188in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYG
2in 2019
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DYG
268in 2025
MAUDE reports naming product code DYG, 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 | 0 | — | 1 | 168 |
| 2008 | 1 | — | 0 | 400 |
| 2009 | 0 | — | 3 | 145 |
| 2010 | 0 | — | 0 | 147 |
| 2011 | 1 | — | 0 | 249 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 149 |
| 2014 | 0 | — | 0 | 178 |
| 2015 | 0 | — | 0 | 163 |
| 2016 | 1 | — | 0 | 154 |
| 2017 | 0 | — | 0 | 115 |
| 2018 | 0 | — | 4 (4) | 133 |
| 2019 | 0 | — | 2 | 144 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 130 |
| 2023 | 1 | — | 0 | 229 |
| 2024 | 3 | 188 | 0 | 226 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Vigilance CCO/SvO2 Monitor is intended to measure both bolus/injectate and continuous cardiac output in addition to mixed venous oxygen saturation. The system also calculates hemodynamic and oxygenation parameters.
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/K955816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955816: Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955816
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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