Cleared Special

K102462 - SYSTEM 1E LIQUID CHEMICAL STERILANT PRO...

K102462 is the FDA 510(k) clearance for SYSTEM 1E LIQUID CHEMICAL STERILANT PRO... by STERIS Corporation. It is a Class 2 General Hospital device (product code MED) cleared through the Special 510(k) pathway after a 25-day FDA review.

K102462 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
25d
Days
Class 2
Risk

K102462 is an FDA 510(k) clearance for the SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 21, 2010 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 STERIS Corporation devices

Submission Details

510(k) Number K102462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2010
Decision Date September 21, 2010
Days to Decision 25 days
Submission Type Special
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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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 - MED Sterilant, Medical Devices

All 26
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K102462.
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · STERIS Corporation · Aug 2016
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · STERIS Corporation · Jul 2013
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K113520 · STERIS Corporation · Feb 2012
SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
K101409 · STERIS Corporation · Aug 2010
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
K091022 · STERIS Corporation · Apr 2010
SYSTEM 1.5 STERILE PROCESSING SYSTEM
K090036 · STERIS Corporation · Apr 2010