510(k) · Cleared
ClearedStablemapr Steerable Intracardiac 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 Aug 5, 1998 after an 89-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Aug 5, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 6 citing it directly.
- This deviceK981642 Stablemapr Steerable Intracardiac CathetersMedtronic Cardiorhythm · 1998
- 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 · 2 generations on · 0 of its ownK052414 Reprocessed Electrophysiology CatheterAlliance Medical Corp. · 2005
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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
- K052414Reprocessed Electrophysiology CatheterAlliance 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) | K981642 | Stablemapr Steerable Intracardiac Catheters | Medtronic Cardiorhythm | 1998 | — |
| +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 | — |
| +2 | K052414 | Reprocessed Electrophysiology Catheter | Alliance Medical Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2019 | 1 | 0 |
| 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 13.6 · 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? (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 | |
| * | — | Irvine Biomedical Steerable Atrial Mapping Inquire H Named without a submission number | |
| * | — | Cordis Webster Halo XP Tricuspid Mapping Catheters Named without a submission number |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012708 | Electrophysiology Catheter | 2002 | 5 |
| K183547 | Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac… | 2019 | 1 |
| K033050 | EN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2, 1060AL1, 1060AL2 | 2004 | 0 |
| K030279 | Reprocessed Electrophysiology Catheter | 2003 | 0 |
| K012678 | Reprocessed Sealed Electrophysiology Diagnostic Catheters | 2002 | 0 |
| K012523 | Reprocessed Electrophysiology Diagnostic Catheters | 2002 | 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?
- 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?
The Medtronic CardioRhythm StableMapr catheter is intended for use in diagnostic electrophysiology procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.
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/K981642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981642: Stablemapr Steerable Intracardiac Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981642
Report an extraction error
Are you the manufacturer?
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