510(k) · Cleared
ClearedConvey Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pendracare International, B.V. · DQY Catheter, Percutaneous
Cleared on Aug 8, 2012 as substantially equivalent to K021256 (Medtronic Vascular, 2002) and 1 other predicate after a 163-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Aug 8, 2012
- Review
- 163 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981198 (1998). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 2 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 1 generation backK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · Recalled
- This deviceK120585 Convey Guiding CatheterPendracare International, B.V. · 2012
- Descendant · cites it directly · 0 of its ownK250972 Primum Hydrophilic Guiding CatheterPendracare · 2025
- Descendant · cites it directly · 0 of its ownK132197 Convey 7F Guiding Catheter, Convey 8F Guiding CatheterPendracare International, B.V. · 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 |
|---|---|---|---|---|---|
| −3 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −2 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −1 | K030779 | 5F Medtronic Launcher Guide Catheter | Medtronic Vascular | 2003 | 7 |
| 0 (this device) | K120585 | Convey Guiding Catheter | Pendracare International, B.V. | 2012 | — |
| +1 | K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025 | — |
| +1 | K132197 | Convey 7F Guiding Catheter, Convey 8F Guiding Catheter | Pendracare International, B.V. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K021256 | Z3 Guide CatheterSummary page 1…artery Definition through the skin using a dilator and a sheath (introducer) or guide wire. Predicate Medtronic LauncherM Guide K021256 17 May 2002 Devices Catheter (6F)II Medtronic LauncherTM Guide K03… | 2002 |
| * | K030779 | 5F Medtronic Launcher Guide CatheterSummary page 1…c LauncherM Guide K021256 17 May 2002 Devices Catheter (6F)II Medtronic LauncherTM Guide K030779 24 April 2003 Catheter (5F)II Device The guiding catheter is a flexible plastic tu… | 2003 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K250972 (Pendracare, 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K021256.
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 Guiding Catheter is designed to provide a pathway through which therapeutic and
diagnostic devices are introduced. The guiding catheter is intended to be used in the coronary
or peripheral vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120585: Convey Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120585
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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