510(k) · Cleared
ClearedTriSalus TriNav® LV 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 May 2, 2023 as substantially equivalent to K180677 (Surefire Medical, Inc., 2018) after a 28-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it.
- Decided
- May 2, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003105 (2001). 10 ancestors in all, the oldest K915414 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
- 7 generations backK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
- 6 generations backK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
- 5 generations backK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
- 4 generations backK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
- 3 generations backK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
- 2 generations backK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
- 1 generation backK180677 Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
- This deviceK230957 TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023
- Descendant · cites it directly · 0 of its ownK253509 TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
Most influential descendants
Showing 1 of 1 · See all- K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003105 | Biosphere Medical Infusion Catheter | Biosphere Medical | 2001 | — |
| −7 | K062126 | Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 | Biosphere Medical, Inc. | 2006 | — |
| −6 | K110459 | Surefire Infusion Catheter System | Surefire Medical, Inc. | 2011 | — |
| −5 | K121677 | Surefire HI-Flow Microcatheter | Surefire Medical, Inc. | 2012 | — |
| −4 | K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015 | — |
| −3 | K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 | — |
| −2 | K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017 | — |
| −1 | K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018 | — |
| 0 (this device) | K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K180677 | Surefire Spark Infusion SystemSummary page 4…ary Product Code: KRA (Primary) Secondary Product Code: DQO (Secondary) Predicate Device Surefire Spark Infusion System (rebranded as TriNav) K180677 Reference Device Surefire Infusion System K160662 Device Description The TriSalus®… | 2018 |
| † | K160662 | Surefire Infusion System | 2016 |
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 |
|---|---|---|---|
| K253509 | TriSalus TriNav Advance Infusion System | 2026 | 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 22 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K253509 (Trisalus Life Sciences, 2026) has gone furthest, with 0 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. 2023, 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® LV 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 as stated in the FDA summary.
https://510kreport.com/device/K230957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230957: TriSalus TriNav® LV 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/K230957
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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