510(k) · Cleared
Recalled · 2009Swan-Ganz Intellicath Cco Thermodilution Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KRA Catheter, Continuous Flush
Cleared on Apr 8, 1993 after a 205-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 8, 1993
- Review
- 205 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 3
- Predicates
- 0
14 later devices descend from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- This deviceK924661 Swan-Ganz Intellicath Cco Thermodilution CatheterBaxter Healthcare Corp · 1993
- Descendant · cites it directly · 13 of its ownK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 3 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · 4 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK241851 Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K160084 Swan Ganz Catheterscites it directly · 2016
Most influential descendants
Showing 5 of 14 · See all- K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · cites it directly13descendants
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 2 generations on6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 3 generations on4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 4 generations on2descendants
- K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924661 | Swan-Ganz Intellicath Cco Thermodilution Catheter | Baxter Healthcare Corp | 1993 | — |
| +1 | K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 | Class I |
| +2 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +3 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +4 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
| +2 | K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KRA device
- #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.4 · 9 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160084 | Swan Ganz Catheters Class I | 2016 | 13 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2009 | Not classified | Z-1240-2009 | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode". |
| Feb 9, 2009 | Not classified | Z-1239-2009 | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode". |
| Feb 9, 2009 | Not classified | Z-1238-2009 | Software design | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode". |
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 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K160084 (Edwards Lifesciences, LLC, 2016) has gone furthest, with 13 descendants of its own.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRA
41so far in 2026, the most since 2007
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KRA
980in 2025
MAUDE reports naming product code KRA, 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 | 5 | 44 | 2 | 118 |
| 2008 | 7 | 144 | 6 | 117 |
| 2009 | 5 | 69 | 8 | 187 |
| 2010 | 2 | — | 26 | 355 |
| 2011 | 2 | — | 3 | 239 |
| 2012 | 3 | 29 | 3 | 217 |
| 2013 | 3 | 126 | 2 | 209 |
| 2014 | 4 | 61 | 3 (2) | 276 |
| 2015 | 0 | — | 1 | 339 |
| 2016 | 8 | 122 | 3 (1) | 418 |
| 2017 | 4 | 166 | 0 | 538 |
| 2018 | 4 | 178 | 0 | 434 |
| 2019 | 4 | 133 | 4 (4) | 418 |
| 2020 | 6 | 29 | 1 | 381 |
| 2021 | 6 | 108 | 0 | 440 |
| 2022 | 6 | 228 | 0 | 543 |
| 2023 | 7 | 63 | 2 | 829 |
| 2024 | 0 | — | 0 | 942 |
| 2025 | 1 | — | 0 | 980 |
| 2026 | 5 | 268 | 41 | — |
https://510kreport.com/device/K924661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924661: Swan-Ganz Intellicath Cco Thermodilution Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924661
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026