510(k) · Cleared
ClearedGore Tri-Lobe Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 3, 2008 as substantially equivalent to K033670 (W. L. Gore & Associates, Inc., 2004) and 3 other predicates after a 100-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 3, 2008
- Review
- 100 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K003495 (2001). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 2 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 1 generation backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
- This deviceK081799 Gore Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK243184 SAT CenterFlow Molding Balloon Catheter (IN20-00313)Strait Access Technologies Holdings · 2025
- Descendant · cites it directly · 0 of its ownK250410 GORE® Tri-Lobe Balloon CatheterW. L. Gore & Associates, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −2 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −1 | K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | 2005 | — |
| 0 (this device) | K081799 | Gore Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2008 | — |
| +1 | K243184 | SAT CenterFlow Molding Balloon Catheter (IN20-00313) | Strait Access Technologies Holdings | 2025 | — |
| +1 | K250410 | GORE® Tri-Lobe Balloon Catheter | W. L. Gore & Associates, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K033670 | Gore Tri-Lobe Balloon CatheterSummary page 2…ially equivalent to the following predicate devices: * GORE Tri-Lobe Balloon Catheter (W. L. GORE & Associates, Flagstaff, AZ) - K033670 * Reliant Stent Graft Balloon Catheter (Medtronic Endovascular Innovations, CA) - K050038… | 2004 |
| * | K050038 | Reliant Stent Graft Balloon CatheterSummary page 2…& Associates, Flagstaff, AZ) - K033670 * Reliant Stent Graft Balloon Catheter (Medtronic Endovascular Innovations, CA) - K050038 , Cook CODA Balloon Catheter (Cook, Inc., Bloomington, IN)- K032869 - EqualizerTM Balloon Catheter… | 2005 |
| * | K032869 | Cook Coda Balloon CatheterSummary page 2…ent Graft Balloon Catheter (Medtronic Endovascular Innovations, CA) - K050038 , Cook CODA Balloon Catheter (Cook, Inc., Bloomington, IN)- K032869 - EqualizerTM Balloon Catheter (Boston Scientific Corporation, Natick, MA) - K021721 Dif… | 2003 |
| * | K021721 | Equalizer Balloon CatheterSummary page 2…CODA Balloon Catheter (Cook, Inc., Bloomington, IN)- K032869 - EqualizerTM Balloon Catheter (Boston Scientific Corporation, Natick, MA) - K021721 Differences between the devices do not raise any significant issues of safety or effectiveness. W. L. G… | 2002 |
What descends from it? (2)
2 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 7 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K243184 (Strait Access Technologies Holdings, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033670.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 GORE Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self expanding endoprostheses in large diameter vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081799: Gore Tri-Lobe Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081799
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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