Cleared Special

K191343 - SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900

K191343 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 Special 510(k) pathway after a 108-day FDA review.

K191343 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
108d
Days
Class 2
Risk

K191343 is an FDA 510(k) clearance for the SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900. 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 5, 2019 after a review of 108 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191343

510(k) Number K191343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date September 05, 2019
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

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 64
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K191343.
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
K210737 · STERIS Corporation · May 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
K192929 · STERIS Corporation · Dec 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System
K190104 · Steris Corporations · Mar 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
K182827 · STERIS Corporation · Jan 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System
K180342 · Steris Corporations · Apr 2018
K191343 · SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
Download PDF FDA Summary STERIS Corporation