510(k) Report

FDA applicant

Selux Diagnostics, Inc.

Charlestown, MA4 decisions2023–20250 recalls

FDA records 4 decisions for Selux Diagnostics, Inc. (Charlestown, MA) from 2023 to 2025: 4 510(k) clearances. Most are in product codes QZX (Positive Blood Culture Processor For Inoculum…) and LON (System, Test, Automated, Antimicrobial…). 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, microbiology panel, where it files most

How often FDA has decided Selux Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 22024: 12025: 1
2023high 2 (2023) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Selux Diagnostics, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial…2decisions
  • LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 20241cites it

What has FDA decided for it lately?

  • K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2025
  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2024
  • K211748Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023
  • K211759Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023

All 4 as Selux Diagnostics, Inc. →