510(k) · Cleared
ClearedSwang-Ganz IQ pulmonary artery catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesiences, LLC · DYG Catheter, Flow Directed
Cleared on Dec 9, 2022 as substantially equivalent to K160084 (Edwards Lifesciences, LLC, 2016) after a 144-day review. Its family tree reaches back 3 generations to 1990. 1 of the 14 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 9, 2022
- Review
- 144 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). 1 later device descends from it, 1 citing it directly. 1 of the 14 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 deviceK222117 Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022
- Descendant · cites it directly · 0 of its ownK233824 Swan-Ganz catheterEdwards Lifesciences, LLC · 2024 · Recalled
Class I recalls in this family
- K160084 Swan Ganz Cathetersdirect predicate · 2016
Most influential descendants
Showing 1 of 1 · See all- K233824Swan-Ganz catheterEdwards Lifesciences, LLC · 2024 · cites it directly0descendants
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) | K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022 | — |
| +1 | K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024 | 1 |
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 |
|---|---|---|
| 2024 | 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…roduct DYG, Class II Code: Predicate The Edwards Swan-Ganz catheters (Models 777F8 and 780F75M), Device(s): manufactured by Edwards Lifesciences, K160084 cleared May 3, 2016, is being utilized for substantial equivalence due to the same basic device… | 2016 |
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 |
|---|---|---|---|
| K233824 | Swan-Ganz catheter | 2024 | 0 |
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 32 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233824 (Edwards Lifesciences, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 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. 2022, 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?
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes: • 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…
Read the full statement (118 words)
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes:
• 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
Secondary indications include the following:
• Blood Sampling
• Infusion of saline and dextrose solutions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222117: Swang-Ganz IQ pulmonary artery catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222117
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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