510(k) · Cleared
ClearedSpinnaker
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 Mar 24, 1997 as substantially equivalent to K923368 (Target Therapeutics, 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Mar 24, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923368 (1993). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K980104Flow Rider Flow Directed Micro CatheterMicro Therapeutics, Inc. · 1998 · cites it directly0descendants
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) | K965189 | Spinnaker | Target Therapeutics | 1997 | — |
| +1 | K980104 | Flow Rider Flow Directed Micro Catheter | Micro Therapeutics, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K923368 | Magic Infusion CatheterSummary page 1…with any other occlusion oils. Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only. EREDICATE DEVICE: Balt Magic Infusion Catheter, K923368 Zephyr Infusion Catheter, K921247 3D TING 1 RT g RS LA : 5 WEIER Substantial equivalence is based on the fact that the Spinnaker… | 1993 |
| * | K921247 | Zephyr Infusion CatheterSummary page 1…te: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only. EREDICATE DEVICE: Balt Magic Infusion Catheter, K923368 Zephyr Infusion Catheter, K921247 3D TING 1 RT g RS LA : 5 WEIER Substantial equivalence is based on the fact that the Spinnaker has similar technological charact… | 1993 |
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 |
|---|---|---|---|
| K980104 | Flow Rider Flow Directed Micro Catheter | 1998 | 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?
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 Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.
The Spinnaker Infusion Catheter in Contraindicated for use with any other occlusion oils.
Note: Compatibility testing has been conducted with the Berenstein Liquid Coil -10 only.
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/K965189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965189: Spinnaker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965189
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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