510(k) Report

FDA applicant

Sauter AG

Sulgen (Tg), CH5 decisions2002–20150 recalls

FDA records 5 decisions for Sauter AG (Sulgen (Tg), CH) from 2002 to 2015: 5 510(k) clearances. All are in product code FLE (Sterilizer, Steam). Its devices cite 3 predicates, 2 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 Sauter AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12015: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 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, Steam5decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K033538Belimed Steam Sterilizer Top 5000, Series 4 - 8Sauter AG · 20043cite it
  • K021223Belimed Steam Sterilizer, Model Top 5000Sauter AG · 20023cite it
  • K060337Belimed Steam Sterilizer Top 5000, Model 5-5-9Sauter AG · 20061cites it

What has FDA decided for it lately?

  • K141879Belimed Steam Sterilizer MST-HSauter AG · 2015
  • K103841Belimed Steam Sterilizer MST-VSauter AG · 2011
  • K060337Belimed Steam Sterilizer Top 5000, Model 5-5-9Sauter AG · 2006
  • K033538Belimed Steam Sterilizer Top 5000, Series 4 - 8Sauter AG · 2004
  • K021223Belimed Steam Sterilizer, Model Top 5000Sauter AG · 2002

All 5 as Sauter AG →