# K043257: Real-Time Position Management (RPM) System

- Pathway: 510(k) (Special)
- Applicant: Ep Technologies, Inc.
- Decided: Feb 3, 2005 after 71 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992912 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992912: Cardiac Pathways Reference Catheter and Reference Catheter with Tracking, Cardiac Pathways Radii Catheter and Radii Cath, Cardiac Pathways Corp. (2000) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K043257
Methodology: https://510kreport.com/methodology