510(k) · Cleared
ClearedIlt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Luminal Therapeutics, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 30, 2001 as substantially equivalent to K001992 (Intra Luminal Therapeutics, Inc., 2000) after a 49-day review. Its family tree reaches back 1 generation to 2000. 1 of the 125 devices in its family, counting itself, has a Class I recall. 123 later devices descend from it.
- Decided
- Aug 30, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001992 (2000). 123 later devices descend from it, 2 citing it directly. 1 of the 125 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- This deviceK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- Descendant · cites it directly · 122 of its ownK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- Descendant · 2 generations on · 120 of its ownK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- Descendant · cites it directly · 119 of its ownK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- Descendant · 2 generations on · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141547 Wingman Extendable Tip Support Catheter7 generations on · 2014
Most influential descendants
Showing 5 of 123 · See all- K030984Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14, Safe Cross…Intra Luminal Therapeutics, Inc. · 2003 · cites it directly122descendants
- K032660Xtrak Support CatheterXtrak Medical, Inc. · 2003 · 2 generations on120descendants
- K051772Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005 · cites it directly119descendants
- K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · 2 generations on44descendants
- K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| 0 (this device) | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| +1 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| +2 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| +1 | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| +2 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +2 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 17 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 1 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
1 device in this family has a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001992 | Ilt 0.014 Catheter, Model C114NL2 | 2000 |
What descends from it? (123)
See all 1232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 7 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 ILT Support Catheter with or without the advancing mechanism is indicated to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The ILT Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
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/K012169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012169: Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism, Model A11AM1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026