510(k) Report

FDA applicant

Advanced Cooling Therapy, Inc. D/B/A Attune Medical

Chicago, IL3 decisions2018–20230 recalls

FDA records 3 decisions for Advanced Cooling Therapy, Inc. D/B/A Attune Medical (Chicago, IL) from 2018 to 2023: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PLA (Esophageal Thermal Regulation And Gastric…) and QXV (Temperature Regulation Device For Esophageal…). Its devices cite 3 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 Advanced Cooling Therapy, Inc. D/B/A Attune Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 22023: 1
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Advanced Cooling Therapy, Inc. D/B/A Attune Medical by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PLAEsophageal Thermal Regulation And Gastric Suctioning Device2decisions
  • QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 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.

  • K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 20181cites it

What has FDA decided for it lately?

  • DEN230021ensoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2023
  • K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018
  • K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical · 2018

All 3 as Advanced Cooling Therapy, Inc. D/B/A Attune Medical →