510(k) · Cleared
ClearedPrimum Hydrophilic Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pendracare · DQY Catheter, Percutaneous
Cleared on Jun 29, 2025 as substantially equivalent to K120585 (Pendracare International, B.V., 2012) after a 90-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Jun 29, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981198 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK981198 Medtronic Zuma Guiding CatheterMedtronics Interventional Vascular · 1998 · Recalled
- 3 generations backK021256 Z3 Guide CatheterMedtronic Vascular · 2002 · Recalled
- 2 generations backK030779 5F Medtronic Launcher Guide CatheterMedtronic Vascular · 2003 · Recalled
- 1 generation backK120585 Convey Guiding CatheterPendracare International, B.V. · 2012
- This deviceK250972 Primum Hydrophilic Guiding CatheterPendracare · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981198 | Medtronic Zuma Guiding Catheter | Medtronics Interventional Vascular | 1998 | 25 |
| −3 | K021256 | Z3 Guide Catheter | Medtronic Vascular | 2002 | 52 |
| −2 | K030779 | 5F Medtronic Launcher Guide Catheter | Medtronic Vascular | 2003 | 7 |
| −1 | K120585 | Convey Guiding Catheter | Pendracare International, B.V. | 2012 | — |
| 0 (this device) | K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K120585 | Convey Guiding CatheterSummary page 6…Page 2 of 9 C. Predicate Device information The legally marketed device which the 510(k) used for claiming equivalence are • Convey 5F Guiding Catheters (K120585, August 8, 2012) • Convey 6F Guiding Catheters (K120585, August 8, 2012) PendraCare International B.V., Leek, The Nethe… | 2012 |
| † | K132197 | Convey 7F Guiding Catheter, Convey 8F Guiding Catheter | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K120585.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K250972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250972: Primum Hydrophilic Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250972
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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