510(k) Report

FDA applicant

Imalux Corporation

Cleveland, OH2 decisions2004–20041 recall

FDA records 2 decisions for Imalux Corporation (Cleveland, OH) in 2004: 2 510(k) clearances. Most are in product codes NQQ (System, Imaging, Optical Coherence Tomography…) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Imalux Corporation since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Imalux Corporation’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?

  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)1decision
  • KKXDrape, Surgical, Antimicrobial1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K042894Imalux Niris Imaging SystemImalux Corporation · 20042cite it
  • K041077Imalux Oct Probe GuideImalux Corporation · 20041cites it

What has FDA decided for it lately?

  • K042894Imalux Niris Imaging SystemImalux Corporation · 20041 recall
  • K041077Imalux Oct Probe GuideImalux Corporation · 2004

All 2 as Imalux Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K042894Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX…Dec 22, 2011

Other applicant names beginning “Imalux”

FDA records each applicant name separately; these may or may not be the same firm.

Imalux Coporation 1