Cleared Abbreviated

K191896 - Belimed Steam Sterilizer MST-H TOP 5000

K191896 is the FDA 510(k) clearance for Belimed Steam Sterilizer MST-H TOP 5000 by Belimed AG. It is a Class 2 General Hospital device (product code FLE) cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K191896 · Belimed AG · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
108d
Days
Class 2
Risk

K191896 is an FDA 510(k) clearance for the Belimed Steam Sterilizer MST-H TOP 5000. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Belimed AG (Zug, CH). The FDA issued a Cleared decision on October 31, 2019 after a review of 108 days - within the typical 510(k) review window.

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 AG devices

Submission Details

510(k) Number K191896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date October 31, 2019
Days to Decision 108 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 66
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