510(k) · Cleared
ClearedSurefire Infusion System 021
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surefire Medical, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 12, 2015 as substantially equivalent to K121677 (Surefire Medical, Inc., 2012) after a 25-day review. Its family tree reaches back 4 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 12, 2015
- Review
- 25 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003105 (2001). 6 ancestors in all, the oldest K915414 (1992). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003105 Biosphere Medical Infusion CatheterBiosphere Medical · 2001
- 3 generations backK062126 Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
- 2 generations backK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
- 1 generation backK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
- This deviceK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK180677 Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK230957 TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023
- Descendant · 4 generations on · 0 of its ownK253509 TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016 · cites it directly5descendants
- K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017 · cites it directly4descendants
- K180677Surefire Spark Infusion SystemSurefire Medical, Inc. · 2018 · 2 generations on2descendants
- K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences · 2023 · 3 generations on1descendant
- K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003105 | Biosphere Medical Infusion Catheter | Biosphere Medical | 2001 | — |
| −3 | K062126 | Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 | Biosphere Medical, Inc. | 2006 | — |
| −2 | K110459 | Surefire Infusion Catheter System | Surefire Medical, Inc. | 2011 | — |
| −1 | K121677 | Surefire HI-Flow Microcatheter | Surefire Medical, Inc. | 2012 | — |
| 0 (this device) | K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015 | — |
| +1 | K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 | — |
| +1 | K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017 | — |
| +2 | K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018 | — |
| +3 | K230957 | TriSalus TriNav® LV Infusion System | Trisalus Life Sciences | 2023 | — |
| +4 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 DQO? 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K121677 | Surefire HI-Flow MicrocatheterSummary page 4…scular Devices Classification Regulation: 21 CFR 870.1200 Product Code: DQO Predicate Device ƒ Surefire Infusion System K121677 Device Description The Surefire Infusion System 021 is a 0.021" lumen coaxial microcatheter with the Surefire Expandable Tip at… | 2012 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K160662 (Surefire Medical, Inc., 2016) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Surefire Infusion System 021 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/K143588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143588: Surefire Infusion System 021.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143588
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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