Cleared Traditional

K173256 - System 1 endo Liquid Chemical Sterilant...

K173256 is an FDA 510(k) clearance for System 1 endo Liquid Chemical Sterilant..., manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with product code MED cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K173256 · STERIS Corporation · General Hospital
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Mar 2018
Decision
143d
Days
Class 2
Risk

K173256 is an FDA 510(k) clearance for the System 1 endo 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 March 2, 2018 after a review of 143 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K173256

510(k) Number K173256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2017
Decision Date March 02, 2018
Days to Decision 143 days
Submission Type Traditional
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
14d slower than avg
Panel avg: 129d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MED Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K173256.
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
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K182827 · STERIS Corporation · Jan 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System
K180342 · Steris Corporations · Apr 2018
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · STERIS Corporation · Sep 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · STERIS Corporation · Aug 2016
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
K131078 · STERIS Corporation · Jul 2013