Cleared Traditional

K021223 - BELIMED STEAM STERILIZER, MODEL TOP 5000

K021223 is an FDA 510(k) clearance for BELIMED STEAM STERILIZER, manufactured by Sauter AG. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K021223 · Sauter AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
69d
Days
Class 2
Risk

K021223 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER, MODEL TOP 5000. 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 June 26, 2002 after a review of 69 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 - K021223

510(k) Number K021223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2002
Decision Date June 26, 2002
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 America, Inc.
MARK JOB

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 K021223.
W & H LISA STEAM STERILIZER
K022816 · A-Dec, Inc. · Feb 2003
QUANTIM 16 AUTOCLAVE
K021064 · Scican · Aug 2002
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K021504 · Tuttnauer U.S.A Co, Ltd. · Jul 2002
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER
K020590 · Getinge/Castle, Inc. · Mar 2002
HARVEY PV DRY STERILIZER, MODEL # ST127325
K014174 · Barnstead/Thermolyne Corp. · Feb 2002

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.