510(k) · Cleared
ClearedTriSalus TriNav Advance Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trisalus Life Sciences · KRA Catheter, Continuous Flush
Cleared on Sep 21, 2026 as substantially equivalent to K230957 (Trisalus Life Sciences, 2023) after a 320-day review. Its family tree reaches back 9 generations to 2001.
- Decided
- Sep 21, 2026
- Review
- 320 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003105 (2001). 11 ancestors in all, the oldest K915414 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
- 5 generations between
- 3 generations backK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
- 2 generations backK180677 Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
- 1 generation backK230957 TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023
- This deviceK253509 TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
Show all 9 generations
- Root · 9 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
- 8 generations backK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
- 7 generations backK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
- 6 generations backK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
- 5 generations backK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
- 4 generations backK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
- 3 generations backK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
- 2 generations backK180677 Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
- 1 generation backK230957 TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023
- This deviceK253509 TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003105 | Biosphere Medical Infusion Catheter | Biosphere Medical | 2001 | — |
| −8 | K062126 | Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 | Biosphere Medical, Inc. | 2006 | — |
| −7 | K110459 | Surefire Infusion Catheter System | Surefire Medical, Inc. | 2011 | — |
| −6 | K121677 | Surefire HI-Flow Microcatheter | Surefire Medical, Inc. | 2012 | — |
| −5 | K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015 | — |
| −4 | K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 | — |
| −3 | K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017 | — |
| −2 | K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018 | — |
| −1 | K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023 | — |
| 0 (this device) | K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2009 | 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 K254051 Extroducer Infusion Catheter Systemscore 13.5 · 6 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 |
|---|---|---|---|
| * | K230957 | TriSalus TriNav® LV Infusion SystemSummary page 5…1210 Product Code(s) KRA, DQO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K230957 TriSalus TriNav LV Infusion System KRA Device Description Summary 21 CFR 807.92(a)(4) The TriSalus TriNav Advance Infusion Syste… | 2023 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 11 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. 2026, 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 TriSalus TriNav Advance Infusion System is intended for use in angiographic procedures. It delivers radiopaque
media and therapeutic agents to selected sites in the peripheral vascular system.
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/K253509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253509: TriSalus TriNav Advance Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253509
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026