510(k) · Cleared
ClearedInstylla Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instylla, Inc. · KRA Catheter, Continuous Flush
Cleared on Apr 21, 2020 as substantially equivalent to K191731 (Instylla, Inc., 2019) after a 29-day review. Its family tree reaches back 4 generations to 2005. 2 later devices descend from it.
- Decided
- Apr 21, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K052841 (2005). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- 3 generations backK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- 2 generations backK093052 Crosscath Support CathterCook, Inc. · 2009
- 1 generation backK191731 Instylla MicrocatheterInstylla, Inc. · 2019
- This deviceK200744 Instylla MicrocatheterInstylla, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK210808 Instylla Microcatheter 1.2Instylla, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261610 Verge™ MicrocatheterInstylla, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −4 | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| −3 | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | 1 |
| −2 | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| −1 | K191731 | Instylla Microcatheter | Instylla, Inc. | 2019 | — |
| 0 (this device) | K200744 | Instylla Microcatheter | Instylla, Inc. | 2020 | — |
| +1 | K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K191731 | Instylla MicrocatheterSummary page 4…Predicate Devices: Proprietary Name: Instylla Microcatheter Manufacturer: Instylla, Inc. 510(k) Number: K191731 Device Description: The Instylla Microcatheter includes a single lumen, multipurpose catheter intended for use in the peripheral… | 2019 |
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 15 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K210808 (Instylla, Inc., 2021) has gone furthest, with 1 descendant 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. 2020, 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 Instylla Microcatheter is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200744 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200744: Instylla Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200744
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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