510(k) Report

FDA applicant

Qbtech AB

Stockholm, SE4 decisions2004–20160 recalls

FDA records 4 decisions for Qbtech AB (Stockholm, SE) from 2004 to 2016: 4 510(k) clearances. All are in product code LQD (Recorder, Attention Task Performance). Its devices cite 4 predicates, 3 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

How often FDA has decided Qbtech AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2012: 12014: 12016: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qbtech AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LQDRecorder, Attention Task Performance4decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K133382QB TestQbtech AB · 20142cite it
  • K122149QBTESQbtech AB · 20122cite it
  • K040894QbtestQbtech AB · 20041cites it

What has FDA decided for it lately?

All 4 as Qbtech AB →