510(k) · Cleared
ClearedSwan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath]
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 Nov 27, 1995 as substantially equivalent to K934742 (Baxter Healthcare Corp, 1994) and 2 other predicates after a 237-day review. Its family tree reaches back 1 generation to 1990. 1 of the 18 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Nov 27, 1995
- Review
- 237 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896466 (1990). 3 ancestors in all. 14 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
- This deviceK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
- Descendant · cites it directly · 13 of its ownK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 3 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 4 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160084 Swan Ganz Catheterscites it directly · 2016
Most influential descendants
Showing 5 of 14 · See all- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · cites it directly13descendants
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 2 generations on6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 3 generations on4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 4 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896466 | Swan-Ganz Thermodilution Ejection Fraction/Volume | Baxter Healthcare Corp | 1990 | — |
| 0 (this device) | K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection… | Baxter Healthcare Corp | 1995 | — |
| +1 | K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 | Class I |
| +2 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +3 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +4 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| +2 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 1 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K934742 | Swan-Ganz Continuous Cardiac Output/Oximetry/Venous PortSummary page 1…Summary 1. Determination of Substantial Equivalence The CCO/SvO+VIPW/REF Catheter is substantially equivalent to the CCO/SvO+VIPm Catheter (K934742) and the REF Catheter (K896466) in that the CCO/Sv02/VIPTM/REF Catheter combines the intended uses of the two predicate… | 1994 |
| * | K896466 | Swan-Ganz Thermodilution Ejection Fraction/VolumeSummary page 1…on of Substantial Equivalence The CCO/SvO+VIPW/REF Catheter is substantially equivalent to the CCO/SvO+VIPm Catheter (K934742) and the REF Catheter (K896466) in that the CCO/Sv02/VIPTM/REF Catheter combines the intended uses of the two predicate devices. Furthermore… | 1990 |
| * | K905458 | Swan-Ganz (R) Flow Direct Oximetry/Thermod CatherSummary page 1…catheters that are indicated for REF measurement. The CCO/SvO#/lPTM/REF Catheter is also substantially equivalent to the Oximetry Paceport Catheter (K905458) in it’s use of tantalum markers to assist in catheter positioning with the use of fluoroscope. Because all aspects of… | 1991 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160084 | Swan Ganz Catheters Class I | 2016 | 13 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
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 CCO/SvOJVIPmlREF Catheter is used for continuous cardiac output (CCO) measurement when used with a Vigilance Monitor, mixed venous oxygen saturation (SVOJ monitoring when used with an Explorer, SAT-2 or Vigilance Monitor, right ventricular ejection fraction (REF) determinations when used with an Explorer or REF-1 Monitor, thermodilution cardiac output measurement when used with a Vigilance, Explorer, COM-2, REF-1, SAT-2, or 9520A monitor, hemodynamic pressure monitoring, blood sampling, and infusion of saline and dextrose solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K951566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951566: Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection Fraction/Volumetric (Cco/SVO2/Vip/Ref) Cath].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951566
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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