Cleared Traditional

K090339 - BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2

K090339 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER TOP 5000, manufactured by Belimed Sauter AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K090339 · Belimed Sauter AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
225d
Days
Class 2
Risk

K090339 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Belimed Sauter AG (Charleston, US). The FDA issued a Cleared decision on September 23, 2009 after a review of 225 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090339

510(k) Number K090339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2009
Decision Date September 23, 2009
Days to Decision 225 days
Submission Type Traditional
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
96d slower than avg
Panel avg: 129d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 177
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K090339.
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
K100622 · Belimed Sauter AG · Aug 2010
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
K093333 · Primus Sterilizer Company, LLC · Apr 2010
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · STERIS Corporation · Nov 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · STERIS Corporation · Sep 2009
TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE
K090783 · Tuttnauer U.S.A Co, Ltd. · Aug 2009
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
K090670 · Midmark Corp. · Jul 2009
K090339 · BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
Download PDF FDA Summary Belimed Sauter AG