Cleared Abbreviated

K170228 - Belimed Steam Sterilizer MST-H TOP 5000

K170228 is an FDA 510(k) clearance for Belimed Steam Sterilizer MST-H TOP 5000, manufactured by Belimed AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 107-day FDA review.

K170228 · Belimed AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
107d
Days
Class 2
Risk

K170228 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 May 12, 2017 after a review of 107 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

FDA 510(k) Submission Details - K170228

510(k) Number K170228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2017
Decision Date May 12, 2017
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Standards-based clearance path.

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

Belimed, Inc.
Jay Upchurch

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 125
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K170228.
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
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Family of Steam Sterilizers B 28 series
K151597 · Cefla S.C. · Mar 2016
BELIMED STEAM STERILIZER MST-H
K141879 · Sauter AG · Jun 2015