510(k) · Cleared
ClearedEN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2, 1060AL1, 1060AL2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Mar 26, 2004 as substantially equivalent to K981642 (Medtronic Cardiorhythm, 1998) after a 179-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 26, 2004
- Review
- 179 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981642 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK981642 Stablemapr Steerable Intracardiac CathetersMedtronic Cardiorhythm · 1998
- This deviceK033050 EN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1…Medtronic Vascular · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981642 | Stablemapr Steerable Intracardiac Catheters | Medtronic Cardiorhythm | 1998 | — |
| 0 (this device) | K033050 | EN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2… | Medtronic Vascular | 2004 | — |
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? (1)
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 |
|---|---|---|---|
| * | K981642 | Stablemapr Steerable Intracardiac CathetersSummary page 1…1642: DRF Predicate Device Name and 5 10(k) StableMapr Number K981642 ____ ____ ____ ____ ____ ____ Cleared August 5, 1998 Device Description:… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K981642.
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 EncircIr AL Adjustable Loop Mapping Catheter is intended for electrophysiologic mapping, recording intracardiac electrograms, and temporary pacing in the atria of the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033050: EN Circlr AL Adjustable Loop Mapping Catheter Models, 1045AL1, 1045AL2, 1060AL1, 1060AL2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033050
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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