510(k) · Cleared
ClearedMagic Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · KRA Catheter, Continuous Flush
Cleared on Apr 7, 1993 after a 272-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Apr 7, 1993
- Review
- 272 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 5 citing it directly.
- This deviceK923368 Magic Infusion CatheterTarget Therapeutics · 1993
- Descendant · cites it directly · 22 of its ownK023351 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
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K023351Magic Infusion CatheterAdvanced Interventional Technologies, LLC · 2003 · cites it directly22descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923368 | Magic Infusion Catheter | Target Therapeutics | 1993 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 265 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?
- Of its descendants, K023351 (Advanced Interventional Technologies, LLC, 2003) has gone furthest, with 22 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 | — |
https://510kreport.com/device/K923368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923368: Magic Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923368
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026