Cleared Special

K033538 - BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8

K033538 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER TOP 5000, manufactured by Sauter AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Special 510(k) pathway after a 84-day FDA review.

K033538 · Sauter AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
84d
Days
Class 2
Risk

K033538 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Sauter AG (Sulgen (Tg), CH). The FDA issued a Cleared decision on February 2, 2004 after a review of 84 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033538

510(k) Number K033538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date February 02, 2004
Days to Decision 84 days
Submission Type Special
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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Modification to existing cleared device. 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 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 153
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K033538.
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
K060337 · Sauter AG · Mar 2006
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
K041833 · Consolidated Machine Corp. · Dec 2004
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
K032192 · Tuttnauer U.S.A Co, Ltd. · Aug 2004
CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
K031259 · Getinge USA, Inc. · May 2003
AMSCO CENTURY STEAM STERILIZER
K030789 · STERIS Corporation · Mar 2003