510(k) · Cleared
ClearedCatheter, Electrode Recording, or Probe, Electrode Recording
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Mar 11, 1996 after a 214-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 214 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK953750 Catheter, Electrode Recording, or Probe, Electrode RecordingBoston Scientific Corp · 1996
- Descendant · cites it directly · 2 of its ownK962765 Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque…Cordis Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK993248 Amplatzer Sizing BalloonAga Medical Corp. · 2000
- Descendant · 3 generations on · 0 of its ownK053440 Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom…Cordis Corp. · 1997 · cites it directly2descendants
- K993248Amplatzer Sizing BalloonAga Medical Corp. · 2000 · 2 generations on1descendant
- K053440Amplatzer Sizing Balloon IIAga Medical Corp. · 2005 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953750 | Catheter, Electrode Recording, or Probe, Electrode Recording | Boston Scientific Corp | 1996 | — |
| +1 | K962765 | Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)… | Cordis Corp. | 1997 | — |
| +2 | K993248 | Amplatzer Sizing Balloon | Aga Medical Corp. | 2000 | — |
| +3 | K053440 | Amplatzer Sizing Balloon II | Aga Medical Corp. | 2005 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | — | Elecath Investigator Named without a submission number | |
| * | — | Daig Response electrophysiology catheters Named without a submission number |
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 |
|---|---|---|---|
| K962765 | Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom… | 1997 | 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, K962765 (Cordis Corp., 1997) 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 electrode catheter is intended for intracardiac electrogram recording and pacing for the
purpose of determining conduction times from one cardiac location to another, to focalize
aberrant conduction pathways and to test for the susceptability of the cardiac chambers to
arrhythmias.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K953750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953750: Catheter, Electrode Recording, or Probe, Electrode Recording.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953750
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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