510(k) · Cleared
ClearedCXI Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KRA Catheter, Continuous Flush
Cleared on Nov 22, 2016 as substantially equivalent to K072724 (Cook, Inc., 2007) after a 236-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- Nov 22, 2016
- Review
- 236 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052841 (2005). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- 1 generation backK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- This deviceK160884 CXI Support CatheterCook Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK222679 Vericor Support CatheterVascupatent Medical (Shenzhen) Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK221886 Sublime MicrocatheterSurmodics,Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| −1 | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | 1 |
| 0 (this device) | K160884 | CXI Support Catheter | Cook Incorporated | 2016 | — |
| +1 | K222679 | Vericor Support Catheter | Vascupatent Medical (Shenzhen) Co., Ltd. | 2022 | — |
| +1 | K221886 | Sublime Microcatheter | Surmodics,Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 2 | 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 14.5 · 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? (1)
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 4…se. Predicate Device: The device, subject of this submission, is substantially equivalent to the predicate device, the CXI™ Support Catheter cleared under 510(k) number K072724. Comparison to Predicate Device: The CXI™ Support Catheter is substantially equivalent to the predicate device, the CXI™ Suppor… | 2007 |
| † | K122796 | Cxi Support Catheter | 2012 |
| † | K111263 | Cxi Triforce | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K222679 (Vascupatent Medical (Shenzhen) Co., Ltd., 2022) 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. 2016, 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 CXI™ 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/K160884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160884: CXI Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160884
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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