510(k) · Cleared
ClearedLumend Frontrunner Cto Catheter and Accessories
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 7, 2004 as substantially equivalent to K031005 (Lumend, Inc., 2003) after a 58-day review. Its family tree reaches back 5 generations to 1994. 31 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K935425 (1994). 9 ancestors in all, the oldest K884647 (1989). 31 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK935425 Metronic Buchbinder Envoy Percutaneous CathetersMedtronics Interventional Vascular · 1994
- 4 generations backK991059 Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics…Spectranetics Corp. · 1999
- 3 generations backK013284 Lumend Frontrunner Cto Coronary CatheterLumend, Inc. · 2002
- 2 generations backK023114 Lumend Frontrunner Cto CatheterLumend, Inc. · 2003
- 1 generation backK031005 Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003
- This deviceK033535 Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004
- Descendant · cites it directly · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 2 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 3 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
- Descendant · 3 generations on · 7 of its ownK140185 Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K111338Wildcat CatheterAvinger, Inc. · 2011 · cites it directly17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 2 generations on14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 3 generations on12descendants
- K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · cites it directly11descendants
- K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc. · 2014 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935425 | Metronic Buchbinder Envoy Percutaneous Catheters | Medtronics Interventional Vascular | 1994 | — |
| −4 | K991059 | Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… | Spectranetics Corp. | 1999 | — |
| −3 | K013284 | Lumend Frontrunner Cto Coronary Catheter | Lumend, Inc. | 2002 | — |
| −2 | K023114 | Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2003 | — |
| −1 | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| 0 (this device) | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
| +1 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +2 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +3 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
| +1 | K102725 | Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model… | Bridge Medical, Inc. | 2011 | 1 |
| +3 | K140185 | Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console | Avinger, Inc. | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031005 | Lumend Frontrunner GW Cto CatheterSummary page 1…er® CTO Catheter and Accessories is substantially equivalent in intended use and method of operation to the following predicate device: LuMend Frontrunner® CTO Catheter K031005 Device Description: The LuMend Frontrunner® CTO Catheter is a sterile single-use percutaneous catheter consisting of a handle a… | 2003 |
What descends from it? (31)
See all 313 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 10 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K111338 (Avinger, Inc., 2011) has gone furthest, with 17 descendants of its own.
- 1 other device also cites its predicate K031005.
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 and Accessories are intended to facilitate the intraluminal placemcnt of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral and coronary vasculature prior to fusther 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/K033535 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033535: Lumend Frontrunner Cto Catheter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033535
Report an extraction error
Are you the manufacturer?
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