510(k) · Cleared
ClearedTriSalus 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 Dec 3, 2019 as substantially equivalent to K171355 (Surefire Medical, Inc., 2017) after a 25-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Dec 3, 2019
- Review
- 25 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003105 (2001). 9 ancestors in all, the oldest K915414 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
- 6 generations backK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
- 5 generations backK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
- 4 generations backK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
- 3 generations backK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
- 2 generations backK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
- 1 generation backK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
- This deviceK193107 TriSalus Infusion SystemTrisalus Life Sciences · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003105 | Biosphere Medical Infusion Catheter | Biosphere Medical | 2001 | — |
| −6 | K062126 | Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 | Biosphere Medical, Inc. | 2006 | — |
| −5 | K110459 | Surefire Infusion Catheter System | Surefire Medical, Inc. | 2011 | — |
| −4 | K121677 | Surefire HI-Flow Microcatheter | Surefire Medical, Inc. | 2012 | — |
| −3 | K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015 | — |
| −2 | K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 | — |
| −1 | K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017 | — |
| 0 (this device) | K193107 | TriSalus Infusion System | Trisalus Life Sciences | 2019 | — |
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 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 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 |
|---|---|---|---|
| * | K171355 | Surefire Precision Infusion SystemSummary page 4…ation: 21 CFR 870.1210 Primary Product Code: KRA Secondary Product Code: DQO Primary Predicate Device Surefire Precision Infusion System K171355 (also marketed as Surefire Infusion System) Reference Predicate Devices Surefire Infusion System 021… | 2017 |
| † | K121677 | Surefire HI-Flow Microcatheter | 2012 |
| † | K180677 | Surefire Spark Infusion System | 2018 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K171355.
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 TriSalus Infusion System is intended for use in angiographic procedures to deliver 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/K193107 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193107: TriSalus Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193107
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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