510(k) Report

FDA applicant

Acutus Medical, Inc.

Carlsbad, CA24 decisions2017–20230 recalls

FDA records 24 decisions for Acutus Medical, Inc. (Carlsbad, CA) from 2017 to 2023: 24 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 19 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Acutus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2017: 32018: 12019: 42020: 42021: 42022: 52023: 3
2017high 5 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Acutus Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acutus Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable12decisions
  • DYBIntroducer, Catheter6decisions
  • MTDCatheter, Intracardiac Mapping, High-Density Array3decisions
  • DRACatheter, Steerable3decisions

How long do its 510(k) reviews take?

Since 2016, its 19 510(k)s took a median of 84 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 14 of its 19 were faster than that.

Whose devices does it build on?

Its devices cite 27 predicates; 19 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210685AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 20212cite it
  • K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 20202cite it
  • K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 20222cite it
  • K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 20172cite it
  • K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 20191cites it
  • K162925AcQGuide Steerable SheathAcutus Medical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K233691FlexCath Cross Transseptal SolutionAcutus Medical, Inc. · 2023
  • K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023
  • K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2023
  • K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022
  • K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc. · 2022
  • K210766AcQMap 3D Imaging and Mapping Catheter, Model 900009Acutus Medical, Inc. · 2022
  • K221044AcQGuide® VUE Steerable SheathAcutus Medical, Inc. · 2022
  • K220047AcQCross Qx Integrated Transseptal Dilator/NeedleAcutus Medical, Inc. · 2022

All 24 as Acutus Medical, Inc. →