510(k) · Cleared
ClearedSwan-Ganz Thermodilution Ejection Fraction/Volume
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 Feb 8, 1990 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- Feb 8, 1990
- Review
- 87 days
- Class
- Class II
- Product code
- DYG
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- This deviceK896466 Swan-Ganz Thermodilution Ejection Fraction/VolumeBaxter Healthcare Corp · 1990
- Descendant · cites it directly · 14 of its ownK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
- Descendant · 2 generations on · 13 of its ownK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 4 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 5 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160084 Swan Ganz Catheters2 generations on · 2016
Most influential descendants
Showing 5 of 15 · See all- K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp · 1995 · cites it directly14descendants
- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · 2 generations on13descendants
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 3 generations on6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 4 generations on4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 | Class I |
| +3 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +4 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +5 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K951566 | Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection… | 1995 | 14 |
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 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K951566 (Baxter Healthcare Corp, 1995) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K896466 · printed Nov 4, 2026
Cite this page
510(k) Report. “K896466: Swan-Ganz Thermodilution Ejection Fraction/Volume.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K896466
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026