510(k) Report

FDA applicant

Ablacon, Inc.

Denver, CO3 decisions2021–20230 recalls

FDA records 3 decisions for Ablacon, Inc. (Denver, CO) from 2021 to 2023: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MTD (Catheter, Intracardiac Mapping, High-Density…). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Ablacon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2021: 12023: 2
2021high 2 (2023) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ablacon, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable2decisions
  • MTDCatheter, Intracardiac Mapping, High-Density Array1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 156 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; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203084Ablamap SoftwareAblacon, Inc. · 20211cites it
  • K223666Ablacath™ Mapping CatheterAblacon, Inc. · 20231cites it
  • K230008Ablamap® SystemAblacon, Inc. · 20231cites it

What has FDA decided for it lately?

  • K230008Ablamap® SystemAblacon, Inc. · 2023
  • K223666Ablacath™ Mapping CatheterAblacon, Inc. · 2023
  • K203084Ablamap SoftwareAblacon, Inc. · 2021

All 3 as Ablacon, Inc. →