510(k) Report

FDA applicant

Belimed Sauter AG

Sulgen (Tg), CH3 decisions2007–20100 recalls

FDA records 3 decisions for Belimed Sauter AG (Sulgen (Tg), CH) from 2007 to 2010: 3 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Its devices cite 4 predicates, 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2010

2007: 12009: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Belimed Sauter AG 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?

  • FLESterilizer, Steam3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K100622Belimed Steam Sterilizer, Model MST-V 3-3-6Belimed Sauter AG · 20101cites it

What has FDA decided for it lately?

  • K100622Belimed Steam Sterilizer, Model MST-V 3-3-6Belimed Sauter AG · 2010
  • K090339Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2Belimed Sauter AG · 2009
  • K072087Belimed Steam Sterilizer Model Top 5000 Series 24Belimed Sauter AG · 2007

All 3 as Belimed Sauter AG →

Other applicant names beginning “Belimed”

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

Belimed AG 3