# K262005: Affera Integrated Mapping System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Aug 21, 2026 after 67 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: 20 generations back to K001437 (2000). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243892: Affera Integrated Mapping System, Medtronic, Inc. (2025) Summary page 5.

## Indications for use
The Affera integrated mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.

Source page: https://510kreport.com/device/K262005
Methodology: https://510kreport.com/methodology