510(k) Report

FDA applicant

Aln Implants Chirurgicaux

Bormes Les Mimosas, FR3 decisions2008–20170 recalls

FDA records 3 decisions for Aln Implants Chirurgicaux (Bormes Les Mimosas, FR) from 2008 to 2017: 3 510(k) clearances. All are in product code DTK (Filter, Intravascular, Cardiovascular). Its devices cite 6 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, cardiovascular panel, where it files most

How often FDA has decided Aln Implants Chirurgicaux’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12012: 12017: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Aln Implants Chirurgicaux by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DTKFilter, Intravascular, Cardiovascular3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN…Aln Implants Chirurgicaux · 20171cites it
  • K070514Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit…Aln Implants Chirurgicaux · 20081cites it

What has FDA decided for it lately?

  • K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN…Aln Implants Chirurgicaux · 2017
  • K113124Aln Optional Vana Cava FilterAln Implants Chirurgicaux · 2012
  • K070514Aln Optional Vena Cava Filter-Femoral Approach, Jugular Approach, Brachial Approach, Extraction Kit…Aln Implants Chirurgicaux · 2008

All 3 as Aln Implants Chirurgicaux →