510(k) · Cleared
ClearedLumend Frontrunner GW 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 Jun 18, 2003 as substantially equivalent to K023223 (Lumend, Inc., 2002) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1994. 32 later devices descend from it.
- Decided
- Jun 18, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935425 (1994). 8 ancestors in all, the oldest K884647 (1989). 32 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 3 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 2 generations backK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
- 1 generation backK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
- This deviceK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
- Descendant · cites it directly · 31 of its ownK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
- Descendant · 2 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 3 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 4 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004 · cites it directly31descendants
- K111338Wildcat CatheterAvinger, Inc. · 2011 · 2 generations on17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 3 generations on14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 4 generations on12descendants
- K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −3 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −2 | K013284 | Lumend Frontrunner Cto Coronary Catheter | Lumend, Inc. | 2002 | — |
| −1 | K023114 | Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2003 | — |
| 0 (this device) | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| +1 | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
| +2 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +3 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +4 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| +1 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model… | Bridge Medical, Inc. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 8 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K023223 | Modification to Lumend Frontrunner Cto CatheterSummary page 1…end Frontrunner™ GW CTO Catheter is substantially cquivalent in intended usc and method of operation to the following predicate device: LuMend Frontrunner™ CTO Catheter K023223 / K023114 Device Description: The LuMend Frontrunner™ GW CTO Catheter is a sterile single-use percutancous catheter consisting… | 2002 |
| * | K023114 | Lumend Frontrunner Cto CatheterSummary page 1…unner™ GW CTO Catheter is substantially cquivalent in intended usc and method of operation to the following predicate device: LuMend Frontrunner™ CTO Catheter K023223 / K023114 Device Description: The LuMend Frontrunner™ GW CTO Catheter is a sterile single-use percutancous catheter consisting of a handl… | 2003 |
What descends from it? (32)
See all 322 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 8 ancestors has a recall.
- Of its descendants, K033535 (Lumend, Inc., 2004) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K023223.
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™ GW 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/K031005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031005: Lumend Frontrunner GW Cto Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031005
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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