510(k) · Cleared
ClearedCrosscath Support Cathter
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 Dec 8, 2009 as substantially equivalent to K072724 (Cook, Inc., 2007) after a 69-day review. Its family tree reaches back 2 generations to 2005. 1 of the 11 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Dec 8, 2009
- Review
- 69 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. 7 later devices descend from it, 3 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- 1 generation backK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- This deviceK093052 Crosscath Support CathterCook, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK191731 Instylla MicrocatheterInstylla, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK200744 Instylla MicrocatheterInstylla, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK210808 Instylla Microcatheter 1.2Instylla, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK122796 Cxi Support CatheterCook, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK261610 Verge™ MicrocatheterInstylla, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161801 CrossCath Support Cathetercites it directly · 2016
Most influential descendants
Showing 5 of 7 · See all- K191731Instylla MicrocatheterInstylla, Inc. · 2019 · cites it directly3descendants
- K200744Instylla MicrocatheterInstylla, Inc. · 2020 · 2 generations on2descendants
- K210808Instylla Microcatheter 1.2Instylla, Inc. · 2021 · 3 generations on1descendant
- K122796Cxi Support CatheterCook, Inc. · 2012 · cites it directly1descendant
- K261610Verge™ MicrocatheterInstylla, Inc. · 2026 · 3 generations on0descendants
View 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) | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| +1 | K191731 | Instylla Microcatheter | Instylla, Inc. | 2019 | — |
| +2 | K200744 | Instylla Microcatheter | Instylla, Inc. | 2020 | — |
| +3 | K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021 | — |
| +1 | K122796 | Cxi Support Catheter | Cook, Inc. | 2012 | — |
| +3 | K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 1 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 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? (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 2…ted 29 September 2009 Substantial Equivalence: Cook Incorporated currently markets the predicate CXI Support Catheter, cleared for marketing on November 9, 2007 (D.C. #K072724). The similar indications for use, principals of operation, and technological characteristics of the CrossCath Support Catheter a… | 2007 |
What descends from it? (7)
3 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)
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.
- K161801CrossCath Support CatheterCook Incorporated · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K191731 (Instylla, Inc., 2019) has gone furthest, with 3 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. 2009, 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 CrossCath 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/K093052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093052: Crosscath Support Cathter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093052
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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