Cleared Special

K060337 - BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060337 · Sauter AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
26d
Days
Class 2
Risk

K060337 is an FDA 510(k) clearance for the BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9. 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 March 8, 2006 after a review of 26 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.

View all Sauter AG devices

Submission Details

510(k) Number K060337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2006
Decision Date March 08, 2006
Days to Decision 26 days
Submission Type Special
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
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

Device Classification

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 183
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