510(k) Report

FDA applicant

Promedon

Essex Junction, VT2 decisions2002–20030 recalls

FDA records 2 decisions for Promedon (Essex Junction, VT) from 2002 to 2003: 2 510(k) clearances. All are in product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Promedon since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K020007Safyre Sling SystemPromedon · 20026cite it

What has FDA decided for it lately?

  • K033691Safyre VS and Safyre TPromedon · 2003
  • K020007Safyre Sling SystemPromedon · 2002

All 2 as Promedon →

Other applicant names beginning “Promedon”

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

Promedon S.A 1