510(k) · Cleared
Recalled · Class I · 2018Swan 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 May 3, 2016 as substantially equivalent to K001063 (Baxter Healthcare Corp, 2000) and 9 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1990. 1 of the 25 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- May 3, 2016
- Review
- 109 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 4 (4 Class I)
- Predicates
- 10
Its longest line of descent runs back 2 generations to K896466 (1990). 11 ancestors in all, the oldest K810124 (1981). 13 later devices descend from it, 6 citing it directly. 1 of the 25 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
- 1 generation backK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
- This deviceK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016
- Descendant · cites it directly · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 2 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 3 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- Descendant · cites it directly · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK222117 Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · cites it directly6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 2 generations on4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 3 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · cites it directly1descendant
- K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896466 | Swan-Ganz Thermodilution Ejection Fraction/Volume | Baxter Healthcare Corp | 1990 | — |
| −1 | K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection… | Baxter Healthcare Corp | 1995 | — |
| 0 (this device) | K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 | — |
| +1 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +2 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +3 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| +1 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
| +1 | K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (10)
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 |
|---|---|---|---|
| * | K001063 | Swan-Ganz Synthetic Controlcath Thermodilution Catheters, Models C146F7, C146HF7…Summary page 6…tinuous flush DYG-870.1240 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566… | 2000 |
| * | K810124 | Swan-Ganz Vip Thermodilution CatheterSummary page 6…lush DYG-870.1240 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566… | 1981 |
| * | K810352 | Swan-Ganz Flow-Directed ThermodilutionSummary page 6…DYG-870.1240 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The… | 1981 |
| * | K820222 | Swan-Ganz Vip-CatheterSummary page 6…DYG-870.1240 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Gan… | 1982 |
| * | K894168 | Swan-Ganz Therm Cath SM Heart Amc Throm 93A102H5FSummary page 6…YG-870.1240 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz cathete… | 1989 |
| * | K905458 | Swan-Ganz (R) Flow Direct Oximetry/Thermod CatherSummary page 6…40 Regulation DQE-870.1230 Class/Product Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz catheters are we… | 1991 |
| * | K910204 | Swan-Ganz (R) HI-Shore (R) Thermo Cath W/Amc (TM)Summary page 6…Code DQO-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz catheters are well known pulmonary artery catheters… | 1991 |
| * | K924661 | Swan-Ganz Intellicath Cco Thermodilution CatheterSummary page 6…-870.1200 KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz catheters are well known pulmonary artery catheters int… | 1993 |
| * | K934742 | Swan-Ganz Continuous Cardiac Output/Oximetry/Venous PortSummary page 6…KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz catheters are well known pulmonary artery catheters intended for… | 1994 |
| * | K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Summary page 6…KRA-870.1210 K001063, K810124, K810352, K820222, K894168, K905458, Predicate Device(s) K910204, K924661, K934742, K951566 The Swan-Ganz catheters are well known pulmonary artery catheters intended for use on c… | 1995 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | 2023 | 6 |
| K241851 | Versus™ Catheter (VS110-8B) | 2024 | 1 |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | 2022 | 1 |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF… | 2026 | 0 |
| K233824 | Swan-Ganz catheter | 2024 | 0 |
| K193466 | Swan-Ganz Catheters | 2020 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2018 | Class I | Z-0763-2019 | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. |
| Dec 21, 2018 | Class I | Z-0764-2019 | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. |
| Dec 21, 2018 | Class I | Z-0765-2019 | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. |
| Dec 21, 2018 | Class I | Z-0762-2019 | Nonconforming Material/Component | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 20.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K231248 (Edwards Lifesciencess, LLC, 2023) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K001063.
How does its category compare?
All DYG devicesDYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 (820 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.
The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. 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.
The Swan-Ganz thermodilution A-V Paceport catheter (Model 991F8) is indicated for the assessment of a patient’s hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. The A-V Paceport catheter (Model 991F8) is also indicated for standby temporary ventricular, atrial, or A-V sequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. 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 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.
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.
The primary indications for the Swan-Ganz CCO thermodilution catheters include:
• Acute heart failure
• Severe hypovolemia
• Complex circulatory situations
• Medical emergencies
• Adult respiratory distress syndrome
• Gram negative sepsis
• Drug intoxication
• Acute renal failure
• Hemorrhagic pancreatitis
• Intra and post-operative management of high risk patients
• History of pulmonary or cardiac disease
• Fluid shifts (e.g., extensive intra-abdominal operations)
• Management of high-risk obstetrical patients
• Diagnosed cardiac disease
• Toxemia
• Premature separation of placenta
• Cardiac output determinations
•Differential diagnosis of mitral regurgitation and ventricular septal rupture
• Diagnosis of cardiac tamponade
Models with CEDV capabilities are also indicated for volumetric determinations
Secondary indications include the following:
• Blood Sampling
• Infusion of saline and dextrose solutions
The primary indications for the CCOmbo EDV TD catheters include:
• Acute heart failure
• Severe hypovolemia
• Complex circulatory situations
• Medical emergencies
• Adult respiratory distress syndrome
• Gram negative sepsis
• Multi system organ failure
• Drug intoxication
• Acute renal failure
• Hemorrhagic pancreatitis
• Intra and post-operative management of high risk patients
• History of pulmonary or cardiac disease
• Fluid shifts (e.g., extensive intra-abdominal operations)
• Management of high-risk obstetrical patients
• Diagnosed cardiac disease
• Toxemia
• Premature separation of placenta
• Cardiac output determinations
• Volumetric determinations
• Differential diagnosis of mitral regurgitation and ventricular septal rupture
• Diagnosis of cardiac tamponade
Secondary indications include the following:
• Blood Sampling
• Infusion of saline and dextrose solutions
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. The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, 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.
The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, 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/K160084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160084: 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/K160084
Report an extraction error
Are you the manufacturer?
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