Cleared Traditional

K170956 - SYSTEM 1E Liquid Chemical Sterilant Processing System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170956 · STERIS Corporation · General Hospital
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Sep 2017
Decision
175d
Days
Class 2
Risk

K170956 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 22, 2017 after a review of 175 days - an extended review cycle.

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.

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Submission Details

510(k) Number K170956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2017
Decision Date September 22, 2017
Days to Decision 175 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 128d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 63
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K170956.
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K222615 · STERIS Corporation · Sep 2022
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
K211607 · STERIS Corporation · Sep 2021
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
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