510(k) · Cleared
ClearedLumend Frontrunner Cto Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumend, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Jan 23, 2003 as substantially equivalent to K013284 (Lumend, Inc., 2002) after a 126-day review. Its family tree reaches back 3 generations to 1994. 69 later devices descend from it.
- Decided
- Jan 23, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935425 (1994). 6 ancestors in all, the oldest K884647 (1989). 69 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 2 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 1 generation backK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
- This deviceK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
- Descendant · cites it directly · 36 of its ownK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- Descendant · cites it directly · 32 of its ownK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
- Descendant · 2 generations on · 31 of its ownK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
- Descendant · 2 generations on · 25 of its ownK043465 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005
- Descendant · 2 generations on · 24 of its ownK052296 Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K040067Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004 · cites it directly36descendants
- K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003 · cites it directly32descendants
- K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004 · 2 generations on31descendants
- K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp. · 2005 · 2 generations on25descendants
- K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp. · 2005 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −2 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −1 | K013284 | Lumend Frontrunner Cto Coronary Catheter | Lumend, Inc. | 2002 | — |
| 0 (this device) | K023114 | Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2003 | — |
| +1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| +1 | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| +2 | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
| +2 | K043465 | 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 | Spectranetics Corp. | 2005 | — |
| +2 | K052296 | Clirpath Turbo Excimer Laser Catheters | Spectranetics Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K013284 | Lumend Frontrunner Cto Coronary CatheterSummary page 1…ntrunner™ CTO Catheter is substantially equivalent in intended use and method of operation to the following predicate device: LuMend Frontrunner™ CTO Coronary Catheter {K013284] Device Description: The LuMend Frontrunner™ is a sterile single-use percutaneous catheter consisting of a handle assembly with… | 2002 |
What descends from it? (69)
See all 693 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 9 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K040067 (Spectranetics Corp., 2004) has gone furthest, with 36 descendants of its own.
- 2 other devices also cite its predicate K013284.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LuMend Frontrunner™ CTO Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to further percutaneous intervention.
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/K023114 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023114: Lumend Frontrunner Cto Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023114
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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