510(k) · Cleared
ClearedEP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Nov 1, 2024 after a 269-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Nov 1, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 2
4 later devices descend from it, 3 citing it directly.
- This deviceK240366 EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™…Boston Scientific Corporation · 2024
- Descendant · cites it directly · 1 of its ownK252794 Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261119 NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252405 Medline ReNewal Reprocessed Boston Scientific Dynamic Tip…Surgical Instrument Service and Savings, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250772 Medline ReNewal Reprocessed Boston Scientific Dynamic XT…Surgical Instrument Service and Savings, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026 · cites it directly1descendant
- K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc. · 2026 · 2 generations on0descendants
- K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…Surgical Instrument Service and Savings, Inc. · 2025 · cites it directly0descendants
- K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…Surgical Instrument Service and Savings, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™… | Boston Scientific Corporation | 2024 | — |
| +1 | K252794 | Vision-MR™ Diagnostic Catheter | Imricor Medical Systems, Inc. | 2026 | — |
| +2 | K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | 2026 | — |
| +1 | K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional… | Surgical Instrument Service and Savings, Inc. | 2025 | — |
| +1 | K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional… | Surgical Instrument Service and Savings, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 2 | 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 DRF? 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K921872 | Bard® Steerable Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…t Device Predicate Device Predicate 510(k) EP•XT Steerable Diagnostic Catheter Bard® Steerable Catheter K921872 Dynamic Tip Steerable Diagnostic Bard® Dynamic Tip Catheter K912213 Cathet… | |
| Kept off the family tree | K912213 | Bard® Dynamic Tip Catheter Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5…eter Bard® Steerable Catheter K921872 Dynamic Tip Steerable Diagnostic Bard® Dynamic Tip Catheter K912213 Catheter Dynamic XT Steerable Diagnostic Bard® Steerable Catheter K92187… |
What descends from it? (4)
3 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?
- Of its descendants, K252794 (Imricor Medical Systems, Inc., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
EP•XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240366 · printed Nov 3, 2026
Cite this page
510(k) Report. “K240366: EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K240366
Report an extraction error
Are you the manufacturer?
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