Cleared Abbreviated

K082435 - AMSCO EVOLUTION MEDIUM STEAM STERILIZER

K082435 is an FDA 510(k) clearance for AMSCO EVOLUTION MEDIUM STEAM STERILIZER, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 130-day FDA review.

K082435 · STERIS Corporation · General Hospital
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Dec 2008
Decision
130d
Days
Class 2
Risk

K082435 is an FDA 510(k) clearance for the AMSCO EVOLUTION MEDIUM STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on December 30, 2008 after a review of 130 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K082435

510(k) Number K082435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2008
Decision Date December 30, 2008
Days to Decision 130 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Standards-based clearance path.

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 123
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K082435.
AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K091731 · STERIS Corporation · Sep 2009
MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
K090670 · Midmark Corp. · Jul 2009
AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
K091136 · STERIS Corporation · Jun 2009
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
K050263 · M.O. Com S.R.L. · Nov 2006
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
K041833 · Consolidated Machine Corp. · Dec 2004
CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003