# K180940: KODEX EPD System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Oct 24, 2018 after 197 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001437 (2000). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133916: Carto 3 EP Navigation System, Version 4.2, Biosense Webster, Inc. (2014) Summary page 4.

## Most influential descendants
- K212493: KODEX – EPD™ System 1.5.0 (2022), 0 descendants of its own

## Indications for use
The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.

Source page: https://510kreport.com/device/K180940
Methodology: https://510kreport.com/methodology