510(k) · Cleared
ClearedMagic Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Interventional Technologies, LLC · KRA Catheter, Continuous Flush
Cleared on Feb 20, 2003 as substantially equivalent to K923368 (Target Therapeutics, 1993) after a 136-day review. Its family tree reaches back 1 generation to 1993. 22 later devices descend from it.
- Decided
- Feb 20, 2003
- Review
- 136 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923368 (1993). 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923368 Magic Infusion CatheterTarget Therapeutics · 1993
- This deviceK023351 Magic Infusion CatheterAdvanced Interventional Technologies, LLC · 2003
- Descendant · cites it directly · 19 of its ownK041826 Ekos Ultrasound Infusion SystemEkos Corp. · 2005
- Descendant · 2 generations on · 18 of its ownK051225 Ekos Micro-Infusion SystemEkos Corp. · 2005
- Descendant · 3 generations on · 16 of its ownK053437 Ekos Micro-Infusion SystemEkos Corp. · 2006
- Descendant · 3 generations on · 16 of its ownK053432 Ekos Micro-Infusion SystemEkos Corp. · 2005
- Descendant · 4 generations on · 14 of its ownK062508 Neurowave Micro-Infusion SystemEkos Corp. · 2006
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K041826Ekos Ultrasound Infusion SystemEkos Corp. · 2005 · cites it directly19descendants
- K051225Ekos Micro-Infusion SystemEkos Corp. · 2005 · 2 generations on18descendants
- K053437Ekos Micro-Infusion SystemEkos Corp. · 2006 · 3 generations on16descendants
- K053432Ekos Micro-Infusion SystemEkos Corp. · 2005 · 3 generations on16descendants
- K062508Neurowave Micro-Infusion SystemEkos Corp. · 2006 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923368 | Magic Infusion Catheter | Target Therapeutics | 1993 | — |
| 0 (this device) | K023351 | Magic Infusion Catheter | Advanced Interventional Technologies, LLC | 2003 | — |
| +1 | K041826 | Ekos Ultrasound Infusion System | Ekos Corp. | 2005 | — |
| +2 | K051225 | Ekos Micro-Infusion System | Ekos Corp. | 2005 | — |
| +3 | K053437 | Ekos Micro-Infusion System | Ekos Corp. | 2006 | — |
| +3 | K053432 | Ekos Micro-Infusion System | Ekos Corp. | 2005 | — |
| +4 | K062508 | Neurowave Micro-Infusion System | Ekos Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K923368 | Magic Infusion CatheterSummary page 1…er Common Name Continuous Flush Catheter Classification Name Catheter, Continuous Flush (21 CFR 0 870.1210) Predicate Device Magic Infusion Catheter (K923368) submitted by Target Therapeutics, Inc. The subject device is the same device as the… | 1993 |
What descends from it? (22)
See all 222 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?
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 Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023351 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023351: Magic Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023351
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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