510(k) · Cleared
ClearedSwan-Ganz Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DYG Catheter, Flow Directed
Cleared on Feb 16, 2020 as substantially equivalent to K160084 (Edwards Lifesciences, LLC, 2016) after a 62-day review. Its family tree reaches back 3 generations to 1990. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Feb 16, 2020
- Review
- 62 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896466 (1990). 12 ancestors in all, the oldest K810124 (1981). No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
- 2 generations backK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
- 1 generation backK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
- This deviceK193466 Swan-Ganz CathetersEdwards Lifesciences, LLC · 2020
Class I recalls in this family
- K160084 Swan Ganz Cathetersdirect predicate · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896466 | Swan-Ganz Thermodilution Ejection Fraction/Volume | Baxter Healthcare Corp | 1990 | — |
| −2 | 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 |
| 0 (this device) | K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 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.
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? (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 |
|---|---|---|---|
| * | K160084 | Swan Ganz CathetersSummary page 5…gnostic intravascular catheter (21 CFR 870.1200) Regulation Class / Class II Product Code DYG, DQE, DQO Primary Predicate K160084- Swan Ganz catheters Device Reference K001063- Swan-Ganz Synthetic ControlCath Thermodilution catheters Pred… | 2016 |
| † | K001063 | Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K160084.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions. Swan‑Ganz thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination…
Read the full statement (237 words)
Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.
Swan‑Ganz thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions.
The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
ControlCath thermodilution catheters and Torque Support Thermodilution catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions.
The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions.
For 631NX55, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193466: Swan-Ganz Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193466
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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