510(k) · Cleared
Recalled · Class II · 2015Cxi 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 Nov 9, 2007 as substantially equivalent to K052841 (Cook, Inc., 2005) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 2005. 1 of the 16 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- KRA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052841 (2005). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- This deviceK072724 Cxi Support CatheterCook, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK093052 Crosscath Support CathterCook, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK191731 Instylla MicrocatheterInstylla, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK200744 Instylla MicrocatheterInstylla, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK160884 CXI Support CatheterCook Incorporated · 2016
- Descendant · 4 generations on · 1 of its ownK210808 Instylla Microcatheter 1.2Instylla, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161801 CrossCath Support Catheter2 generations on · 2016
Most influential descendants
Showing 5 of 13 · See all- K093052Crosscath Support CathterCook, Inc. · 2009 · cites it directly7descendants
- K191731Instylla MicrocatheterInstylla, Inc. · 2019 · 2 generations on3descendants
- K200744Instylla MicrocatheterInstylla, Inc. · 2020 · 3 generations on2descendants
- K160884CXI Support CatheterCook Incorporated · 2016 · cites it directly2descendants
- K210808Instylla Microcatheter 1.2Instylla, Inc. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| 0 (this device) | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | — |
| +1 | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| +2 | K191731 | Instylla Microcatheter | Instylla, Inc. | 2019 | — |
| +3 | K200744 | Instylla Microcatheter | Instylla, Inc. | 2020 | — |
| +1 | K160884 | CXI Support Catheter | Cook Incorporated | 2016 | — |
| +4 | K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 3 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K052841 | Mira-Flex 18 MicrocatheterSummary page 1…lective anatomy for diagnostics and interventional procedures. The device most similar is the MiraFlex 18 Microcatheter cleared for marketing on December 8, 2005 (D.C.#K052841) and March 6, 2006 (D.C.#K060224). The similar indications for use, principles of operation, technological characteristics and… | 2005 |
| * | K060224 | Modification to Mira-Flex 18 MicrocatheterSummary page 1…nd interventional procedures. The device most similar is the MiraFlex 18 Microcatheter cleared for marketing on December 8, 2005 (D.C.#K052841) and March 6, 2006 (D.C.#K060224). The similar indications for use, principles of operation, technological characteristics and performance testing results fo… | 2006 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2015 | Class II | Z-0244-2016 | Labeling mix-ups | Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the products were mixed during processing. |
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.
- K161801CrossCath Support CatheterCook Incorporated · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K093052 (Cook, Inc., 2009) has gone furthest, with 7 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. 2007, 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?
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/K072724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072724: Cxi Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072724
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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