Cleared Abbreviated

K112403 - AMSCO CHIMERON MEDIUM STEAM STERLILZER

K112403 is the FDA 510(k) clearance for AMSCO CHIMERON MEDIUM STEAM STERLILZER by STERIS Corporation. It is a Class 2 General Hospital device (product code FLE) cleared through the Abbreviated 510(k) pathway after a 260-day FDA review.

K112403 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
260d
Days
Class 2
Risk

K112403 is an FDA 510(k) clearance for the AMSCO CHIMERON MEDIUM STEAM STERLILZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 260 days - an extended review 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 K112403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2011
Decision Date May 08, 2012
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
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 63
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K112403.
Amsco Evolution Medium Steam Sterilizer
K173485 · STERIS Corporation · Feb 2018
Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)
K173490 · STERIS Corporation · Feb 2018
Getinge GSS67N Series Steam Sterilizer
K172159 · Maquet GmbH · Jan 2018
AMSCO CHIMERON MEDIUM STEAM STERILIZER
K112055 · STERIS Corporation · Dec 2011
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · STERIS Corporation · Sep 2011
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · STERIS Corporation · Nov 2009