510(k) · Cleared
ClearedReflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805
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 May 12, 2004 after a 107-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- May 12, 2004
- Review
- 107 days
- Class
- Class II
- Product code
- DRA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK040165 Reflexion Cannulator Steerable Electrophysiology Catheter with…St Jude Medical · 2004
- Descendant · cites it directly · 4 of its ownK052575 Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical · 2006
- Descendant · 2 generations on · 2 of its ownK103083 Agilis ES Steerable IntroducerSt Jude Medical · 2011
- Descendant · 3 generations on · 1 of its ownK171557 AcQRef Introducer SheathAcutus Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK200721 Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical) · 2020
- Descendant · 4 generations on · 0 of its ownK192106 AcQRef Introducer SheathAcutus Medical, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K052575Luminary Cannulator Bideflectable Catheter with LumenSt Jude Medical · 2006 · cites it directly4descendants
- K103083Agilis ES Steerable IntroducerSt Jude Medical · 2011 · 2 generations on2descendants
- K171557AcQRef Introducer SheathAcutus Medical, Inc. · 2018 · 3 generations on1descendant
- K200721Agilis HisPro Steerable Catheter With ElectrodesAbbott (St. Jude Medical) · 2020 · 2 generations on0descendants
- K192106AcQRef Introducer SheathAcutus Medical, Inc. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040165 | Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model… | St Jude Medical | 2004 | — |
| +1 | K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | St Jude Medical | 2006 | — |
| +2 | K103083 | Agilis ES Steerable Introducer | St Jude Medical | 2011 | — |
| +3 | K171557 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2018 | — |
| +2 | K200721 | Agilis HisPro Steerable Catheter With Electrodes | Abbott (St. Jude Medical) | 2020 | — |
| +4 | K192106 | AcQRef Introducer Sheath | Acutus Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | 6F Reflexion Bidirectional Electrophysiology Catheter Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052575 | Luminary Cannulator Bideflectable Catheter with Lumen | 2006 | 4 |
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?
- Of its descendants, K052575 (St Jude Medical, 2006) has gone furthest, with 4 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 St. Jude Medical (SJM) Reflexion Cannulator T M Steerable Electrophysiology Catheter with Lumen can 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/K040165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040165: Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040165
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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