510(k) · Cleared
ClearedMira-Flex 18 Microcatheter
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, 2005 after a 62-day review. The FDA summary names no predicate by number. 1 of the 15 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.
- Decided
- Dec 8, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- 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 deviceK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- Descendant · cites it directly · 13 of its ownK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK093052 Crosscath Support CathterCook, Inc. · 2009
- Descendant · 3 generations on · 3 of its ownK191731 Instylla MicrocatheterInstylla, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK200744 Instylla MicrocatheterInstylla, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK160884 CXI Support CatheterCook Incorporated · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K161801 CrossCath Support Catheter3 generations on · 2016
Most influential descendants
Showing 5 of 14 · See all- K072724Cxi Support CatheterCook, Inc. · 2007 · cites it directly13descendants
- K093052Crosscath Support CathterCook, Inc. · 2009 · 2 generations on7descendants
- K191731Instylla MicrocatheterInstylla, Inc. · 2019 · 3 generations on3descendants
- K200744Instylla MicrocatheterInstylla, Inc. · 2020 · 4 generations on2descendants
- K160884CXI Support CatheterCook Incorporated · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| +1 | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | 1 |
| +2 | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| +3 | K191731 | Instylla Microcatheter | Instylla, Inc. | 2019 | — |
| +4 | K200744 | Instylla Microcatheter | Instylla, Inc. | 2020 | — |
| +2 | K160884 | CXI Support Catheter | Cook Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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 14.5 · 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K072724 | Cxi Support Catheter | 2007 | 13 |
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 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K072724 (Cook, Inc., 2007) 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 | — |
What is it indicated for?
The Mira-FleXTM 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. Supplied sterile in peel-open packages. Intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052841: Mira-Flex 18 Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052841
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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