Cleared Abbreviated

K103841 - BELIMED STEAM STERILIZER MST-V

K103841 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER MST-V, manufactured by Sauter AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 83-day FDA review.

K103841 · Sauter AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
83d
Days
Class 2
Risk

K103841 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER MST-V. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sauter AG (Sulgen (Tg), CH). The FDA issued a Cleared decision on March 15, 2011 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K103841

510(k) Number K103841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2010
Decision Date March 15, 2011
Days to Decision 83 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FLE Sterilizer, Steam

All 153
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K103841.
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K103504 · Getinge Sourcing, LLC · Mar 2011
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K100622 · Belimed Sauter AG · Aug 2010
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K093333 · Primus Sterilizer Company, LLC · Apr 2010
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · STERIS Corporation · Nov 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.