510(k) · Cleared
Recalled · Class II · 2026Swan-Ganz catheter
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 Jun 6, 2024 as substantially equivalent to K160084 (Edwards Lifesciences, LLC, 2016) and 1 other predicate after a 188-day review. Its family tree reaches back 4 generations to 1990. 1 of the 14 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Jun 6, 2024
- Review
- 188 days
- Class
- Class II
- Product code
- DYG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896466 (1990). 13 ancestors in all, the oldest K810124 (1981). No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
- 3 generations backK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
- 2 generations backK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
- 1 generation backK222117 Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022
- This deviceK233824 Swan-Ganz catheterEdwards Lifesciences, LLC · 2024
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 |
|---|---|---|---|---|---|
| −4 | K896466 | Swan-Ganz Thermodilution Ejection Fraction/Volume | Baxter Healthcare Corp | 1990 | — |
| −3 | K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection… | Baxter Healthcare Corp | 1995 | — |
| −2 | K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 | Class I |
| −1 | K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022 | — |
| 0 (this device) | K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024 | — |
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? (2)
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…21 CFR §870.1210 – Catheter, Continuous Flush Product Code DYG, DQE, DQO and KRA Regulation Class Class II Predicate Device K160084, K222117 Reference Device K231248 The Swan-Ganz catheters are flow-directed pulmonary artery cathe… | 2016 |
| * | K222117 | Swang-Ganz IQ pulmonary artery catheterSummary page 5…21 CFR §870.1210 – Catheter, Continuous Flush Product Code DYG, DQE, DQO and KRA Regulation Class Class II Predicate Device K160084, K222117 Reference Device K231248 The Swan-Ganz catheters are flow-directed pulmonary artery catheters… | 2022 |
| † | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2026 | Class II | Z-2202-2026 | Process change control | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. |
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 34 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 4 of the 13 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. 2024, 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 Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of
adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis,
burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233824: Swan-Ganz catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233824
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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