Cleared Traditional

K233943 - Affera Mapping System (AFR-00003) (FDA 510(k) Clearance)

Also includes:
Location Reference Patch Kit (AFR-00007) System Cart (AFR-00013)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K233943 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
85d
Days
Class 2
Risk

K233943 is an FDA 510(k) clearance for the Affera Mapping System (AFR-00003). Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 8, 2024 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic, Inc. devices

Submission Details

510(k) Number K233943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date March 08, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05120193 Completed Interventional Industry-sponsored

Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

Treatment of Persistent Atrial Fibrillation With the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System

477
Patients (actual)
23
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Atrial Fibrillation
Study design Parallel
Eligibility All sexes · 18 Years+
Sponsor Medtronic Cardiac Ablation Solutions (industry)
Started 2021-12-14 → Primary completion 2024-01-10
Primary outcome
Percent of Subjects With a Primary Adverse Event
Secondary outcome
Energy Application Time
View full study on ClinicalTrials.gov

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 426
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K233943.
EnSite™ X EP System
K260212 · Abbott Medical · Apr 2026
ACORYS MAPPING SYSTEM
K253861 · Corify Care S.L · Apr 2026
Synchrony
K253473 · Stereotaxis, Inc. · Apr 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3)
K254089 · Centerline Biomedical, Inc. · Feb 2026