Cleared Traditional

K243812 - Volta AF-Xplorer (FDA 510(k) Clearance)

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

K243812 · Volta Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
149d
Days
Class 2
Risk

K243812 is an FDA 510(k) clearance for the Volta AF-Xplorer. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Volta Medical (Marseille, FR). The FDA issued a Cleared decision on May 9, 2025 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Volta Medical devices

Submission Details

510(k) Number K243812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2024
Decision Date May 09, 2025
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
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.

Regulatory Consultant

Hogan Lovells US LLP
Kristin Duggan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04702451 Completed Interventional Industry-sponsored

Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

377
Patients (actual)
26
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Atrial Fibrillation
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Isabel Deisenhofer, MD
Sponsor Volta Medical (industry)
Started 2021-02-12 → Primary completion 2023-12-27
Primary outcome
Number of Participants Free From Documented AF After One Ablation Procedure
Secondary outcome
Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures
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 K243812.
EnSite™ X EP System
K260212 · Abbott Medical · Apr 2026
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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