BELIMED STEAM STERILIZER MST-H— 510(k) K141879

Name: FDA 510(k) clearance K141879
Creator: U.S. Food and Drug Administration
Published: 2015-06-17

Substantially Equivalent

Sauter AG

FDA 510(k) clearance K141879 for BELIMED STEAM STERILIZER MST-H, Substantially Equivalent on 2015-06-17. Applicant: Sauter AG. Device class: 2.

Clearance details

Applicant: Sauter AG
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 2014-07-11
Decision date: 2015-06-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sulgen (Tg), CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code FLE

view all

K261055 — AMSCO 700 Steam Sterilizer2026-06-24
K260254 — Enbio PRO2026-02-26
K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
K250164 — Cassette Autoclave (ACA5)2025-08-14

More clearances from Sauter AG

view all

K103841 — BELIMED STEAM STERILIZER MST-V2011-03-15
K060337 — BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-92006-03-08
K033538 — BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 82004-02-02
K021223 — BELIMED STEAM STERILIZER, MODEL TOP 50002002-06-26

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.