510(k) · Cleared
ClearedMAGIC Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · KRA Catheter, Continuous Flush
Cleared on Jan 29, 2021 as substantially equivalent to K023351 (Advanced Interventional Technologies, LLC, 2003) after a 163-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jan 29, 2021
- Review
- 163 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923368 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK923368 Magic Infusion CatheterTarget Therapeutics · 1993
- 1 generation backK023351 Magic Infusion CatheterAdvanced Interventional Technologies, LLC · 2003
- This deviceK202366 MAGIC Infusion CatheterBalt USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK213435 MAGIC Flow-Dependent MicrocatheterBalt USA, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K213435MAGIC Flow-Dependent MicrocatheterBalt USA, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923368 | Magic Infusion Catheter | Target Therapeutics | 1993 | — |
| −1 | K023351 | Magic Infusion Catheter | Advanced Interventional Technologies, LLC | 2003 | — |
| 0 (this device) | K202366 | MAGIC Infusion Catheter | Balt USA, LLC | 2021 | — |
| +1 | K213435 | MAGIC Flow-Dependent Microcatheter | Balt USA, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K023351 | Magic Infusion CatheterSummary page 4…ous Flush NAME: DEVICE Class II, 21 CFR 870.1210 CLASSIFICATION: PRODUCT CODE: KRA PREDICATE MAGIC Infusion Catheter (K023351) DEVICE: The MAGIC Infusion Catheter is intended for regional infusion of… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213435 | MAGIC Flow-Dependent Microcatheter | 2022 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 17.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213435 (Balt USA, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023351.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 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/K202366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202366: 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/K202366
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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