510(k) · Cleared
ClearedLuminary Cannulator Bideflectable Catheter with Lumen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · DRA Catheter, Steerable
Cleared on Jan 19, 2006 as substantially equivalent to K040165 (St Jude Medical, 2004) and 1 other predicate after a 122-day review. Its family tree reaches back 5 generations to 1989. 4 later devices descend from it.
- Decided
- Jan 19, 2006
- Review
- 122 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K893658 (1989). 43 ancestors in all, the oldest K760385 (1976). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
- 4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
- 3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- 2 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- 1 generation backK031211 Attain Prevail Steerable Catheter Set, Model 6228CTHMedtronic Vascular · 2003
- This deviceK052575 Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical · 2006
- Descendant · cites it directly · 2 of its ownK103083 Agilis ES Steerable IntroducerSt Jude Medical · 2011
- Descendant · 2 generations on · 1 of its ownK171557 AcQRef Introducer SheathAcutus Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK200721 Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical) · 2020
- Descendant · 3 generations on · 0 of its ownK192106 AcQRef Introducer SheathAcutus Medical, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K103083Agilis ES Steerable IntroducerSt Jude Medical · 2011 · cites it directly2descendants
- K171557AcQRef Introducer SheathAcutus Medical, Inc. · 2018 · 2 generations on1descendant
- K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical) · 2020 · cites it directly0descendants
- K192106AcQRef Introducer SheathAcutus Medical, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K893658 | Percutaneous Introducer | Medamicus, Inc. | 1989 | — |
| −4 | K965167 | Percutaneous Venous Introducer 10264 | Medamicus, Inc. | 1997 | — |
| −3 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| −2 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| −1 | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTH | Medtronic Vascular | 2003 | — |
| 0 (this device) | K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | St Jude Medical | 2006 | — |
| +1 | K103083 | Agilis ES Steerable Introducer | St Jude Medical | 2011 | — |
| +2 | K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018 | — |
| +1 | K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | 2020 | — |
| +3 | K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1977 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 DRA? 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 DRA device
- #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 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 |
|---|---|---|---|
| * | K040165 | Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805Summary page 1…Class II, 21 CFR 870.1280 Predicate Devices: * St. Jude Medical Reflexion CannulatorTM Steerable Electrophysiology Catheter with Lumen (K040165) * Medtronic AttainTM Prevail® 6228CTH Steerable Catheter Set (K/31211) Device Description: The Luminary Cannulato… | 2004 |
| * | K031211 | Attain Prevail Steerable Catheter Set, Model 6228CTHSummary page 3…ntially equivalent to the St. Jude Medical Reflexion CannulatorFM with Lumen (K040165) and Medtronic AttainTM Prevail® 6228 CTH Steerable Catheter Set (K031211). Page 3 ol 3 DEPARTME… | 2003 |
What descends from it? (4)
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 17 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 43 ancestors have a recall of any class.
- Of its descendants, K103083 (St Jude Medical, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRA devicesDRA Catheter, Steerable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRA
89in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRA
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRA
4,018in 2025
MAUDE reports naming product code DRA, 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 | 1 | — | 0 | 6 |
| 2008 | 1 | — | 1 | 23 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 29 | 0 | 2 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 4 | 70 | 0 | 89 |
| 2013 | 0 | — | 0 | 113 |
| 2014 | 1 | — | 0 | 212 |
| 2015 | 1 | — | 0 | 350 |
| 2016 | 4 | 123 | 0 | 481 |
| 2017 | 2 | — | 0 | 625 |
| 2018 | 1 | — | 0 | 633 |
| 2019 | 2 | — | 0 | 700 |
| 2020 | 1 | — | 0 | 703 |
| 2021 | 1 | — | 0 | 741 |
| 2022 | 2 | — | 0 | 652 |
| 2023 | 3 | 89 | 0 | 788 |
| 2024 | 0 | — | 0 | 1,962 |
| 2025 | 1 | — | 0 | 4,018 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
The Luminary CannulatorTM Bideflectable Catheter with Lumen is indicated to provide a pathway for delivery and support of transvenous devices and fluids to the coronary sinus and coronary vasculature of the heart. The Luminary CannulatorTM Bideflectable Catheter with Lumen can also be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites when minimizing blood loss is essential.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052575 · printed Nov 3, 2026
Cite this page
510(k) Report. “K052575: Luminary Cannulator Bideflectable Catheter with Lumen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K052575
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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