# K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 1, 2024 after 130 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: 18 generations back to K001437 (2000). 59 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233943: Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013), Medtronic, Inc. (2024) Summary page 5.
- K201148: EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License, Abbott Medical (2020) Summary page 5.

## Most influential descendants
- K243892: Affera Integrated Mapping System (2025), 1 descendant of its own
- K262005: Affera Integrated Mapping System (2026), 0 descendants of its own
- K250747: Globe® Pulsed Field System (2025), 0 descendants of its own
- K243435: Magnetic Localization Patch Kit (AFR-00021) (2024), 0 descendants of its own

## Indications for use
Affera Integrated Mapping System: 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. Impedance Localization Patch Kit: Refer to the instructions for use accompanying the compatible electrophysiology catheter(s) used with the compatible mapping system for the specific indications for use.

Source page: https://510kreport.com/device/K241828
Methodology: https://510kreport.com/methodology