510(k) · Cleared
ClearedUnballoon Non-Occlusive Modeling Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · DQY Catheter, Percutaneous
Cleared on Aug 8, 2012 as substantially equivalent to K110891 (LeMaitre Vascular, Inc., 2011) after a 47-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 8, 2012
- Review
- 47 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003495 (2001). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003495 Ancure Lliac Balloon CatheterGuidant Cardiac and Vascular Surgery · 2001
- 3 generations backK032869 Cook Coda Balloon CatheterCook, Inc. · 2003
- 2 generations backK050038 Reliant Stent Graft Balloon CatheterMedtronic Endovascular Innovations · 2005
- 1 generation backK110891 The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive…LeMaitre Vascular, Inc. · 2011
- This deviceK121839 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK123531 Unballoon Non-Occlusive Modeling CatheterLeMaitre Vascular, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK133026 Unballoon Non-Occlusion Modeling CatheterLeMaitre Vascular, Inc. · 2013
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 |
|---|---|---|---|---|---|
| −4 | K003495 | Ancure Lliac Balloon Catheter | Guidant Cardiac and Vascular Surgery | 2001 | — |
| −3 | K032869 | Cook Coda Balloon Catheter | Cook, Inc. | 2003 | — |
| −2 | K050038 | Reliant Stent Graft Balloon Catheter | Medtronic Endovascular Innovations | 2005 | — |
| −1 | K110891 | The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling… | LeMaitre Vascular, Inc. | 2011 | — |
| 0 (this device) | K121839 | Unballoon Non-Occlusive Modeling Catheter | LeMaitre Vascular, Inc. | 2012 | — |
| +1 | K123531 | Unballoon Non-Occlusive Modeling Catheter | LeMaitre Vascular, Inc. | 2012 | — |
| +1 | K133026 | Unballoon Non-Occlusion Modeling Catheter | LeMaitre Vascular, Inc. | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110891 | The Unballoon Non-Occlusive Catheter; the Unballoon Non-Occlusive Modeling Catheter | 2011 |
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 11 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K123531 (LeMaitre Vascular, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K110891.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121839: Unballoon Non-Occlusive Modeling Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121839
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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