510(k) · Cleared
ClearedLumend Percutaneous 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 Jan 16, 2002 as substantially equivalent to K001992 (Intra Luminal Therapeutics, Inc., 2000) and 2 other predicates after a 240-day review. Its family tree reaches back 1 generation to 2000. 1 of the 109 devices in its family, counting itself, has a Class I recall. 105 later devices descend from it.
- Decided
- Jan 16, 2002
- Review
- 240 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000677 (2000). 3 ancestors in all. 105 later devices descend from it, 3 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK000677 Zuma Guide CathetersMedtronic Vascular · 2000
- This deviceK011562 Lumend Percutaneous CatheterLumend, Inc. · 2002
- Descendant · cites it directly · 80 of its ownK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 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 · 35 of its ownK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
- Descendant · cites it directly · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- Descendant · 3 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
Showing 5 of 105 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 105 · See all- K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005 · cites it directly80descendants
- K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · 2 generations on44descendants
- K082337Minnie Support CatheterVascular Solutions, Inc. · 2009 · 2 generations on35descendants
- K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · cites it directly24descendants
- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000677 | Zuma Guide Catheters | Medtronic Vascular | 2000 | — |
| 0 (this device) | K011562 | Lumend Percutaneous Catheter | Lumend, Inc. | 2002 | — |
| +1 | K052258 | Vascular Solutions Skyway Support Catheter | Vascular Solutions, Inc. | 2005 | — |
| +2 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +2 | K082337 | Minnie Support Catheter | Vascular Solutions, Inc. | 2009 | — |
| +1 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| +3 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 8 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 14 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 1 |
| 2015 | 5 | 0 |
| 2016 | 10 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (3)
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 C114NL2Summary page 1…s substantially equivalent in intended use and/or method of operation design and materials to a combination of the following predicate devices: L. ILT™ (.014” Catheter (K001992), 2. Medtronic Zuma™ Guiding Catheters (K000677) and 3. Guidant Viking Optima™ Guiding Catheter (K001435) Device Description: T… | 2000 |
| * | K000677 | Zuma Guide CathetersSummary page 1…r method of operation design and materials to a combination of the following predicate devices: L. ILT™ (.014” Catheter (K001992), 2. Medtronic Zuma™ Guiding Catheters (K000677) and 3. Guidant Viking Optima™ Guiding Catheter (K001435) Device Description: The LuMend Percutaneous Catheter is a sterile sin… | 2000 |
| * | K001435 | Viking Optima Guiding CatheterSummary page 1…on of the following predicate devices: L. ILT™ (.014” Catheter (K001992), 2. Medtronic Zuma™ Guiding Catheters (K000677) and 3. Guidant Viking Optima™ Guiding Catheter (K001435) Device Description: The LuMend Percutaneous Catheter is a sterile single-use percutaneous coronary catheter consisting of a gu… | 2000 |
What descends from it? (105)
See all 1053 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 LuMend Percutaneous Catheter is intended to be used in conjunction with a steerable
guide wire in order to access discreet regions of the coronary vasculature. It may be used
to facilitate placement of guide wires and other interventional devices.
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/K011562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011562: Lumend Percutaneous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011562
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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