510(k) · Cleared
ClearedModification to Lumend Frontrunner Cto Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumend, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 24, 2002 after a 27-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 33 later devices descend from it.
- Decided
- Oct 24, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
33 later devices descend from it, 2 citing it directly.
- This deviceK023223 Modification to Lumend Frontrunner Cto CatheterLumend, Inc. · 2002
- 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 · 3 generations on · 17 of its ownK111338 Wildcat CatheterAvinger, Inc. · 2011
- Descendant · 4 generations on · 14 of its ownK122380 Ocelot SystemAvinger, Inc. · 2012
- Descendant · 5 generations on · 12 of its ownK123532 Ocelot Pixl CatheterAvinger, Inc. · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K031005Lumend Frontrunner GW Cto CatheterLumend, Inc. · 2003 · cites it directly32descendants
- K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc. · 2004 · 2 generations on31descendants
- K111338Wildcat CatheterAvinger, Inc. · 2011 · 3 generations on17descendants
- K122380Ocelot SystemAvinger, Inc. · 2012 · 4 generations on14descendants
- K123532Ocelot Pixl CatheterAvinger, Inc. · 2012 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023223 | Modification to Lumend Frontrunner Cto Catheter | Lumend, Inc. | 2002 | — |
| +1 | K031005 | Lumend Frontrunner GW Cto Catheter | Lumend, Inc. | 2003 | — |
| +2 | K033535 | Lumend Frontrunner Cto Catheter and Accessories | Lumend, Inc. | 2004 | — |
| +3 | K111338 | Wildcat Catheter | Avinger, Inc. | 2011 | — |
| +4 | K122380 | Ocelot System | Avinger, Inc. | 2012 | — |
| +5 | K123532 | Ocelot Pixl Catheter | Avinger, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K132841 | FDA’s K132841 is Zyno Medical Administration Set Our reading of the summary gave K132841, which FDA decided on Jan 23, 2014, after this device was decided (Oct 24, 2002), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1…CTO Catheter is substantially equivalent in intended use and method of operation to the following predicate device: LuMend FrontrunnerThfCTO Coronary Catheter [KO 132841 Device Description: The LuMend FrontrunnerTMCTO Catheter is a sterile single-use percutaneous catheter consisting of a handle a… | 2014 |
What descends from it? (33)
See all 332 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?
- Of its descendants, K031005 (Lumend, Inc., 2003) has gone furthest, with 32 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The LuMend Frontrunner CTO Coronary Catheter is intended to facilitate the intra-luminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) prior to PTCA or stent intervention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023223: Modification to Lumend Frontrunner 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/K023223
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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