Cleared Abbreviated

K130172 - BELIMED STEAM STERILIZER MST-V

K130172 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER MST-V, manufactured by Belimed, Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 242-day FDA review.

K130172 · Belimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
242d
Days
Class 2
Risk

K130172 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 Belimed, Inc. (Charleston, US). The FDA issued a Cleared decision on September 23, 2013 after a review of 242 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.

FDA 510(k) Submission Details - K130172

510(k) Number K130172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2013
Decision Date September 23, 2013
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 Peers - FLE Sterilizer, Steam

All 153
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