510(k) Report

FDA applicant

Braincool AB

Lund, SE4 decisions2017–20230 recalls

FDA records 4 decisions for Braincool AB (Lund, SE) from 2017 to 2023: 3 510(k) clearances and 1 De Novo grant. Most are in product codes DWJ (System, Thermal Regulating) and QUA (Intraoral Cooling Device). 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 Braincool AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12018: 12022: 12023: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

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Which product codes does it file in?

  • DWJSystem, Thermal Regulating2decisions
  • QUAIntraoral Cooling Device1decision
  • NZEHyperthermia Monitor1decision

Whose devices does it build on?

Its devices cite 3 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.

  • DEN210027The Cooral SystemBraincool AB · 20221cites it
  • K162523The IQool SystemBraincool AB · 20171cites it
  • K180375The IQoolTM Warm SystemBraincool AB · 20181cites it

What has FDA decided for it lately?

  • K232844The IQoolTM SystemBraincool AB · 2023
  • DEN210027The Cooral SystemBraincool AB · 2022
  • K180375The IQoolTM Warm SystemBraincool AB · 2018
  • K162523The IQool SystemBraincool AB · 2017

All 4 as Braincool AB →