510(k) Report

FDA applicant

Ontex International NV

Austin, TX1 decision2009–20090 recalls

FDA records 1 decision for Ontex International NV (Austin, TX) in 2009: 1 510(k) clearance. All are in product code HEB (Tampon, Menstrual, Unscented). Its devices cite 1 predicate, 0 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Ontex International NV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Ontex International NV by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HEBTampon, Menstrual, Unscented1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K090819Ontex Tampon (Unscented)Ontex International NV · 20093cite it

What has FDA decided for it lately?

  • K090819Ontex Tampon (Unscented)Ontex International NV · 2009

The one decision as Ontex International NV →

Other applicant names beginning “Ontex”

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

Ontex Bvba 6