Cleared Traditional

K210680 - AcQMap High Resolution Imaging and Mapping System

K210680 is an FDA 510(k) clearance for AcQMap High Resolution Imaging and Mapp..., manufactured by Acutus Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K210680 · Acutus Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
150d
Days
Class 2
Risk

K210680 is an FDA 510(k) clearance for the AcQMap High Resolution Imaging and Mapping System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 5, 2021 after a review of 150 days - an extended review 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: 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 Acutus Medical, Inc. devices

FDA 510(k) Submission Details - K210680

510(k) Number K210680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2021
Decision Date August 05, 2021
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 363
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K210680.
Ablamap Software
K203084 · Ablacon, Inc. · Aug 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · Acutus Medical, Inc. · Aug 2021
iMap 3D Mapping & Navigation System (iMap System)
K201094 · Cardionxt, Inc. · Aug 2021
HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
K211465 · Edwards Lfesciences · Jul 2021
iLab Polaris Multi-Modality Guidance System
K210889 · Boston Scientific Corporation · Jun 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
K203687 · Edwards Lifesciences, LLC · May 2021