Cleared Traditional

K021223 - BELIMED STEAM STERILIZER

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)
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.

View all Sauter AG devices

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
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 Peers - FLE Sterilizer, Steam

All 87
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K021223.
AMSCO CENTURY STEAM STERILIZER
K030789 · STERIS Corporation · Mar 2003
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K023348 · Midmark Corp. · Mar 2003
W & H LISA STEAM STERILIZER
K022816 · A-Dec, Inc. · Feb 2003
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000