510(k) · Cleared
ClearedCxi Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · KRA Catheter, Continuous Flush
Cleared on Oct 11, 2012 as substantially equivalent to K072724 (Cook, Inc., 2007) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it.
- Decided
- Oct 11, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K052841 (2005). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- 2 generations backK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- 1 generation backK093052 Crosscath Support CathterCook, Inc. · 2009
- This deviceK122796 Cxi Support CatheterCook, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK162384 TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) · 2016
Most influential descendants
Showing 1 of 1 · See all- K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| −2 | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | 1 |
| −1 | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| 0 (this device) | K122796 | Cxi Support Catheter | Cook, Inc. | 2012 | — |
| +1 | K162384 | TrailBlazer Angled Support Catheter | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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.
Planning a device in KRA? 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? (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 |
|---|---|---|---|
| * | K072724 | Cxi Support CatheterSummary page 1…is substantially equivalent to the CXITM Support Catheter and the CrossCathTM Support Catheter, manufactured by Cook Incorporated, which are cleared under 510(k) numbers K072724 and K093052, respectively. Comparison to Predicate Device: It has been demonstrated that the CXITM Support Catheter is comparab… | 2007 |
| * | K093052 | Crosscath Support CathterSummary page 1…ally equivalent to the CXITM Support Catheter and the CrossCathTM Support Catheter, manufactured by Cook Incorporated, which are cleared under 510(k) numbers K072724 and K093052, respectively. Comparison to Predicate Device: It has been demonstrated that the CXITM Support Catheter is comparable to the pr… | 2009 |
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 |
|---|---|---|---|
| K162384 | TrailBlazer Angled Support Catheter | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K162384 (Medtronic Vascular, Inc.(Formerly Ev3 Inc.), 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072724.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The CXITM Support Catheter is intended for use in small vessel or superselective anatomy
for diagnostic and interventional procedures, including peripheral use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122796: Cxi Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122796
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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