510(k) Report

FDA applicant

Q-Linea AB

Uppsala, SE2 decisions2024–20260 recalls

FDA records 2 decisions for Q-Linea AB (Uppsala, SE) from 2024 to 2026: 2 510(k) clearances. All are in product code SAN (Automated Antimicrobial Susceptibility Test…). Its devices cite 2 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Q-Linea AB by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB · 20241cites it

What has FDA decided for it lately?

  • K253573ASTar BC G- KitQ-Linea AB · 2026
  • K221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB · 2024

All 2 as Q-Linea AB →