510(k) Report

FDA applicant

Clever Culture Systems AG

Bach, CH3 decisions2016–20210 recalls

FDA records 3 decisions for Clever Culture Systems AG (Bach, CH) from 2016 to 2021: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PPU (Microbial Colony Image Assessment System) and QQY (Culture Plate Imaging System For Qualitative…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Clever Culture Systems”.

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 Clever Culture Systems AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12019: 12021: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Clever Culture Systems AG by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PPUMicrobial Colony Image Assessment System2decisions
  • QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms1decision

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 20192cite it
  • K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA…Clever Culture Systems · 20212cite it
  • DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 20161cites it

What has FDA decided for it lately?

  • K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA…Clever Culture Systems · 2021
  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
  • DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016

All 2 as Clever Culture Systems AG →The one decision as Clever Culture Systems →