510(k) · Cleared
Recalled · 2005Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Pathways Corp. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Mar 8, 2000 after a 191-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 8, 2000
- Review
- 191 days
- Class
- Class II
- Product code
- DRF
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK992912 Cardiac Pathways Reference Catheter and Reference Catheter with…Cardiac Pathways Corp. · 2000
- Descendant · cites it directly · 0 of its ownK043257 Real-Time Position Management (RPM) SystemEp Technologies, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK013349 Astronomer Plus SystemEp Technologies, Inc. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking… | Cardiac Pathways Corp. | 2000 | — |
| +1 | K043257 | Real-Time Position Management (RPM) System | Ep Technologies, Inc. | 2005 | — |
| +1 | K013349 | Astronomer Plus System | Ep Technologies, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 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? (6)
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 |
|---|---|---|---|
| * | — | Biosense Carto™ System Named without a submission number | |
| * | — | Radii™ Diagnostic Electrophysiology Catheter Named without a submission number | |
| * | — | Navi-Star® Catheter Named without a submission number | |
| * | — | Fixed Curve Diagnostic Electrophysiology Catheter Named without a submission number | |
| * | — | Ref-Star® Catheter Named without a submission number | |
| * | — | 5F SUPRA CS™ Diagnostic Electrophysiology Catheter Named without a submission number |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2005 | Not classified | Z-0112-06 | Other | The device has the potential for overheating its transformer and has the potential for fire hazard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043257 (Ep Technologies, Inc., 2005) has gone furthest, with 0 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 Cardiac Pathways Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.
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/K992912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992912: Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992912
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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