# K233160: NeuTrace EP Mapping System v.2.1

- Pathway: 510(k) (Traditional)
- Applicant: Anumana, Inc.
- Decided: Nov 25, 2023 after 59 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.
No later device cites it as a predicate yet.
0 of 24 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 5.

## Indications for use
The NeuTrace EP Mapping System v2.1 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The NeuTrace EP Mapping System v2.1 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 in the right atrium. The system has no special contraindications.

Source page: https://510kreport.com/device/K233160
Methodology: https://510kreport.com/methodology