510(k) · Cleared
ClearedRenegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · KRA Catheter, Continuous Flush
Cleared on May 15, 2014 as substantially equivalent to K100892 (Boston Scientific Corp, 2010) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- May 15, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- KRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000177 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000177 Renegade HI-Flo MicrocatheterBoston Scientific Corp · 2000 · Recalled
- 1 generation backK100892 Renegade HI-Flo Fathom Kit Model M001182XXXBoston Scientific Corp · 2010
- This deviceK140329 Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System…Boston Scientific · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000177 | Renegade HI-Flo Microcatheter | Boston Scientific Corp | 2000 | 5 |
| −1 | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXX | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K140329 | Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit | Boston Scientific | 2014 | — |
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? (2)
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 |
|---|---|---|---|
| * | K100892 | Renegade HI-Flo Fathom Kit Model M001182XXXSummary page 1…210 Product Code: KRA Classification Panel: Cardiovascular Predicate Device Renegade TM Hl-FLOTM FATHOMTM Kit (K100892, 12 April 2010) Renegade HI-FLO Microcatheter and Kit (K0001 77, 07 April 2000) Device… | 2010 |
| * | K000177 | Renegade HI-Flo MicrocatheterSummary page 1…icate Device Renegade TM Hl-FLOTM FATHOMTM Kit (K100892, 12 April 2010) Renegade HI-FLO Microcatheter and Kit (K0001 77, 07 April 2000) Device The Boston Scientific Renegade HI-FLO Microcatheter Description devices are single lume… | 2000 |
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 14 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K100892.
How does its category compare?
All KRA devicesKRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Renegade HI-FLO FATHOM Kit / System is intended for peripheral vascular use. The FATHOM guidewire can be used to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially…
Read the full statement (119 words)
The Renegade HI-FLO FATHOM Kit / System is intended for peripheral vascular use. The FATHOM guidewire can be used to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140329: Renegade HI-Flo Microcatheter, Microcatheter Kit, Fathom System, Fathom Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140329
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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