Cleared Abbreviated

AMSCO CENTURY MEDIUM STERILIZER 26 X 26 (K020747) - FDA 510(k) Clearance

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

K020747 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
71d
Days
Class 2
Risk

K020747 is an FDA 510(k) clearance for the AMSCO CENTURY MEDIUM STERILIZER 26 X 26. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Erie, US). The FDA issued a Cleared decision on May 17, 2002 after a review of 71 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all STERIS Corporation devices

Submission Details

510(k) Number K020747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date May 17, 2002
Days to Decision 71 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K020747.
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