510(k) · Cleared
ClearedMarinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jul 30, 2019 as substantially equivalent to K951347 (Medtronic Cardiorhythm, 1995) and 2 other predicates after a 222-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jul 30, 2019
- Review
- 222 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K931794 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- This deviceK183547 Marinr Steerable Intracardiac Electrode Catheter, StableMapr…Medtronic · 2019
- Descendant · cites it directly · 0 of its ownK212593 ViaCath, AcQRate Dx Steerable CatheterBiotronick, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212593ViaCath, AcQRate Dx Steerable CatheterBiotronick, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| 0 (this device) | K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable… | Medtronic | 2019 | — |
| +1 | K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K951347 | Marinr Series EP Diagnosti CathetersSummary page 4…CFR 870.1220, Cardiovascular Product Code: DRF Predicate Device: 1. Marinr™ Steerable Intracardiac Electrode Catheter (K951347, K931794) 2. StableMapr™ Steerable Intracardiac Electrode Catheter (K98164… | 1995 |
| * | K931794 | Marinr Series EP Diagnostic CathetersSummary page 4…1220, Cardiovascular Product Code: DRF Predicate Device: 1. Marinr™ Steerable Intracardiac Electrode Catheter (K951347, K931794) 2. StableMapr™ Steerable Intracardiac Electrode Catheter (K981642) Devic… | 1994 |
| * | K981642 | Stablemapr Steerable Intracardiac CathetersSummary page 4…Catheter (K951347, K931794) 2. StableMapr™ Steerable Intracardiac Electrode Catheter (K981642) Device Description: Medtronic diagnostic catheters are flexible radiopaque catheters constructe… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | 2021 | 0 |
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?
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. 2019, 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?
1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
2. The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183547: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183547
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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