# K243892: Affera Integrated Mapping System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jan 17, 2025 after 30 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). 60 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit, Medtronic, Inc. (2024) Summary page 5.

## Most influential descendants
- K262005: Affera Integrated Mapping System (2026), 0 descendants of its own

## 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/K243892
Methodology: https://510kreport.com/methodology