Cleared Traditional

BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 (K072087) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072087 · Belimed Sauter AG · General Hospital
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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.

View all Belimed Sauter AG devices

Submission Details

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
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.

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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