Cleared Traditional

K072087 - BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24

K072087 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER MODEL 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 67-day FDA review.

K072087 · Belimed Sauter AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
67d
Days
Class 2
Risk

K072087 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24. 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 October 5, 2007 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K072087

510(k) Number K072087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2007
Decision Date October 05, 2007
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

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 177
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K072087.
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
K090265 · Scican , Ltd. · May 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · STERIS Corporation · Dec 2008
STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101
K072466 · Scican , Ltd. · Dec 2007
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
K063681 · Mediline Italia S.R.L. · Jun 2007
GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER
K070657 · Getinge Sourcing, LLC · Apr 2007
TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
K063711 · Tuttnauer Co. , Ltd. · Feb 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K072087 · BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24
Download PDF FDA Summary Belimed Sauter AG