Cleared Abbreviated

K100622 - BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6

K100622 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER, manufactured by Belimed Sauter AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 176-day FDA review.

K100622 · Belimed Sauter AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
176d
Days
Class 2
Risk

K100622 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Belimed Sauter AG (Sulgen (Tg), CH). The FDA issued a Cleared decision on August 27, 2010 after a review of 176 days - an extended review 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 Belimed Sauter AG devices

FDA 510(k) Submission Details - K100622

510(k) Number K100622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2010
Decision Date August 27, 2010
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 91
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K100622.
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K090670 · Midmark Corp. · Jul 2009