510(k) · Cleared
ClearedVerge™ 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 Jun 11, 2026 as substantially equivalent to K210808 (Instylla, Inc., 2021) and 1 other predicate after a 28-day review. Its family tree reaches back 6 generations to 2005.
- Decided
- Jun 11, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K052841 (2005). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK052841 Mira-Flex 18 MicrocatheterCook, Inc. · 2005
- 5 generations backK072724 Cxi Support CatheterCook, Inc. · 2007 · Recalled
- 4 generations backK093052 Crosscath Support CathterCook, Inc. · 2009
- 3 generations backK191731 Instylla MicrocatheterInstylla, Inc. · 2019
- 2 generations backK200744 Instylla MicrocatheterInstylla, Inc. · 2020
- 1 generation backK210808 Instylla Microcatheter 1.2Instylla, Inc. · 2021
- This deviceK261610 Verge™ MicrocatheterInstylla, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K052841 | Mira-Flex 18 Microcatheter | Cook, Inc. | 2005 | — |
| −5 | K072724 | Cxi Support Catheter | Cook, Inc. | 2007 | 1 |
| −4 | K093052 | Crosscath Support Cathter | Cook, Inc. | 2009 | — |
| −3 | K191731 | Instylla Microcatheter | Instylla, Inc. | 2019 | — |
| −2 | K200744 | Instylla Microcatheter | Instylla, Inc. | 2020 | — |
| −1 | K210808 | Instylla Microcatheter 1.2 | Instylla, Inc. | 2021 | — |
| 0 (this device) | K261610 | Verge™ Microcatheter | Instylla, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 14.4 · 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 |
|---|---|---|---|
| * | K210808 | Instylla Microcatheter 1.2Summary page 5…te Device: Proprietary Name: Instylla 1.2 Microcatheter Manufacturer: Instylla, Inc. 510(k) Number: K210808 Secondary Predicate Device: Proprietary Name: Instylla Microcatheter Manufacturer:… | 2021 |
| * | K200744 | Instylla MicrocatheterSummary page 5…dicate Device: Proprietary Name: Instylla Microcatheter Manufacturer: Instylla, Inc. 510(k) Number: K200744 Device Description: The Verge™ Microcatheter device is a single lumen, multipurpose catheter intended for use in the peripheral… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Verge™ Microcatheter is intended for use in small vessel or subselective anatomy for peripheral vascular diagnostic and interventional procedures. The Verge™ Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261610: Verge™ Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261610
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026