510(k) · Cleared
ClearedPerformr Series EP Diagnostic Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Cardiorhythm · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jan 23, 1997 after a 90-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jan 23, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK964272 Performr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1997
- Descendant · cites it directly · 5 of its ownK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
- Descendant · cites it directly · 0 of its ownK082935 Vision Wire Coronary GuidewireBiotronik, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK052603 Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K012708Electrophysiology CatheterAlliance Medical Corp. · 2002 · cites it directly5descendants
- K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on1descendant
- K082935Vision Wire Coronary GuidewireBiotronik, Inc. · 2008 · cites it directly0descendants
- K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005 · 2 generations on0descendants
- K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964272 | Performr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1997 | — |
| +1 | K012708 | Electrophysiology Catheter | Alliance Medical Corp. | 2002 | 29 |
| +2 | K043393 | Reprocessed EP Technologies Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
| +1 | K082935 | Vision Wire Coronary Guidewire | Biotronik, Inc. | 2008 | — |
| +2 | K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. | 2005 | — |
| +2 | K052603 | Reprocessed Daig Livewire Electrophysiology Catheters | Alliance Medical Corp. | 2005 | 26 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2008 | 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 13.7 · 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? (3)
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 |
|---|---|---|---|
| * | — | Medtronic CardioRhythm Marinr EP catheter Named without a submission number | |
| * | — | Bard EP-XT Steerable Named without a submission number | |
| * | — | Elecath Genesis catheters Named without a submission number |
What descends from it? (7)
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?
- Of its descendants, K012708 (Alliance Medical Corp., 2002) has gone furthest, with 5 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?
A diagnostic electrophysiology catheter is used to record electrical activity from within the heart and to stimulate the heart in accordance with various programmed electrical stimulation protocols incorporated into an EP diagnostic study. All catheters connect physician stimulator/recorder equipment to the desired region of the heart and carry analog signals. Data from the EP study is used to assess arrhythmia patient prognosis, guide therapy selection and evaluate the effectiveness of previously selected therapeutic interventions.
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/K964272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964272: Performr Series EP Diagnostic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964272
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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