510(k) · Cleared
ClearedReal-Time Position Management (RPM) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ep Technologies, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Feb 3, 2005 as substantially equivalent to K992912 (Cardiac Pathways Corp., 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 3, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992912 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK992912 Cardiac Pathways Reference Catheter and Reference Catheter with…Cardiac Pathways Corp. · 2000 · Recalled
- This deviceK043257 Real-Time Position Management (RPM) SystemEp Technologies, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking… | Cardiac Pathways Corp. | 2000 | 1 |
| 0 (this device) | K043257 | Real-Time Position Management (RPM) System | Ep Technologies, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K992912 | Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac…Summary page 1…Predicate Device Information Predicate Device: Arrhythmia Mapping and Tracking System (K992912) Predicate Device Manufacturer: Boston Scientific Corporation Predicate Device Common Name Si… | 2000 |
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 a recall.
- 1 other device also cites its predicate K992912.
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 Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Position Management (RPMTM) System to provide catheter location information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043257: Real-Time Position Management (RPM) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043257
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