510(k) · Cleared
ClearedHereaeus Poseidon Microcatheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Medical Components, LLC · KRA Catheter, Continuous Flush
Cleared on Dec 19, 2019 as substantially equivalent to K131772 (Cook, Inc., 2014) after a 219-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Dec 19, 2019
- Review
- 219 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K060224 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK060224 Modification to Mira-Flex 18 MicrocatheterCook Incorporated · 2006
- 3 generations backK080737 Miraflex High Flow MicrocatheterCook, Inc. · 2008
- 2 generations backK101450 Cantata MicrocatheterCook, Inc. · 2010
- 1 generation backK131772 Cantata (R) 2.9 MicrocatheterCook, Inc. · 2014
- This deviceK191305 Hereaeus Poseidon MicrocatheterHeraeus Medical Components, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060224 | Modification to Mira-Flex 18 Microcatheter | Cook Incorporated | 2006 | — |
| −3 | K080737 | Miraflex High Flow Microcatheter | Cook, Inc. | 2008 | — |
| −2 | K101450 | Cantata Microcatheter | Cook, Inc. | 2010 | — |
| −1 | K131772 | Cantata (R) 2.9 Microcatheter | Cook, Inc. | 2014 | — |
| 0 (this device) | K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | 2019 | — |
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 |
|---|---|---|---|
| * | K131772 | Cantata (R) 2.9 MicrocatheterSummary page 4…Continuous flush catheter, Percutaneous catheter Product Code: KRA, DQY Predicate Device: The subject device is substantially equivalent to K131772; Cook Cantata Microcatheter manufactured by Cook, Incorporated. Device Description: The Poseidon Microca… | 2014 |
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 13 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Poseidon Microcatheter is intended for use in peripheral and coronary vessels for diagnostic and interventional procedures including small or superselective anatomy.
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/K191305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191305: Hereaeus Poseidon Microcatheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191305
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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