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)
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.

View all Sauter AG devices

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
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 Peers - FLE Sterilizer, Steam

All 87
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K103841.
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