510(k) · Cleared
ClearedMarinr Series EP Diagnosti 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 May 10, 1995 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 10, 1995
- Review
- 71 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK951347 Marinr Series EP Diagnosti CathetersMedtronic Cardiorhythm · 1995
- Descendant · cites it directly · 5 of its ownK012708 Electrophysiology CatheterAlliance Medical Corp. · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK183547 Marinr Steerable Intracardiac Electrode Catheter, StableMapr…Medtronic · 2019
- Descendant · 2 generations on · 1 of its ownK043393 Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005
- Descendant · 2 generations on · 0 of its ownK212593 ViaCath, AcQRate Dx Steerable CatheterBiotronick, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK181897 Reprocessed Marinr Diagnostic EP CatheterInnovative Health, LLC · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K012708Electrophysiology CatheterAlliance Medical Corp. · 2002 · cites it directly5descendants
- K183547Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac…Medtronic · 2019 · cites it directly1descendant
- K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp. · 2005 · 2 generations on1descendant
- K212593ViaCath, AcQRate Dx Steerable CatheterBiotronick, Inc. · 2021 · 2 generations on0descendants
- K181897Reprocessed Marinr Diagnostic EP CatheterInnovative Health, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951347 | Marinr Series EP Diagnosti Catheters | Medtronic Cardiorhythm | 1995 | — |
| +1 | K012708 | Electrophysiology Catheter | Alliance Medical Corp. | 2002 | 29 |
| +1 | K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable… | Medtronic | 2019 | — |
| +2 | K043393 | Reprocessed EP Technologies Electrophysiology Catheters | Alliance Medical Corp. | 2005 | — |
| +2 | K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | 2021 | — |
| +1 | K181897 | Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 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 | — |
https://510kreport.com/device/K951347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951347: Marinr Series EP Diagnosti Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951347
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026