510(k) · Cleared
Recalled · Class II · 2015Swan-Ganz CC0/SVO2 Thermodilution Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Edwards · DYG Catheter, Flow Directed
Cleared on May 24, 1994 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 24, 1994
- Review
- 91 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK940795 Swan-Ganz CC0/SVO2 Thermodilution CatheterBaxter Edwards · 1994
- Descendant · cites it directly · 0 of its ownK955816 Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) MonitorBaxter Healthcare Corp · 1997 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K955816Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) MonitorBaxter Healthcare Corp · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940795 | Swan-Ganz CC0/SVO2 Thermodilution Catheter | Baxter Edwards | 1994 | — |
| +1 | K955816 | Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor | Baxter Healthcare Corp | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K955816 | Vigilance Continuous Cardiac Output/Oximetry (Cco/SVO2) Monitor | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2015 | Class II | Z-1700-2015 | Process control | The product failed to meet the internal established statistical test requirement for heparin activity. |
| 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?
- Of its descendants, K955816 (Baxter Healthcare Corp, 1997) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K940795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940795: Swan-Ganz CC0/SVO2 Thermodilution Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940795
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026