# K252302: CARTO™ 3 EP Navigation System V8.1

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Aug 22, 2025 after 29 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: 19 generations back to K001437 (2000). 30 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231207: CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U), Biosense Webster, Inc. (2023) Summary page 5.

## Most influential descendants
- K252972: CARTO™ 3 EP Navigation System V8.4 (2026), 0 descendants of its own
- K254085: CARTO™ 3 EP Navigation System V9.0 with PIU Plus (2026), 0 descendants of its own

## Indications for use
The intended use of the CARTO™ 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO™ 3 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. The system has no special contraindications.

Source page: https://510kreport.com/device/K252302
Methodology: https://510kreport.com/methodology