510(k) · Cleared
ClearedEP Deflectable Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ep Medsystems, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Apr 15, 2004 after a 115-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Apr 15, 2004
- Review
- 115 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK033963 EP Deflectable CathetersEp Medsystems, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK041638 Targetscan Biopsy KitEnvisioneering, LLC · 2004
- Descendant · 2 generations on · 1 of its ownK073399 Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007
- Descendant · 3 generations on · 0 of its ownK081323 Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy…B-K Medical Aps · 2008
Most influential descendants
Showing 3 of 3 · See all- K041638Targetscan Biopsy KitEnvisioneering, LLC · 2004 · cites it directly2descendants
- K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007 · 2 generations on1descendant
- K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033963 | EP Deflectable Catheters | Ep Medsystems, Inc. | 2004 | — |
| +1 | K041638 | Targetscan Biopsy Kit | Envisioneering, LLC | 2004 | — |
| +2 | K073399 | Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide | Envisioneering, LLC | 2007 | — |
| +3 | K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 | B-K Medical Aps | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 13.6 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041638 | Targetscan Biopsy Kit | 2004 | 2 |
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, K041638 (Envisioneering, LLC, 2004) has gone furthest, with 2 descendants 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.
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?
The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033963: EP Deflectable Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033963
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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