Cleared Special

K232914 - SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) (FDA 510(k) Clearance)

Also includes:
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232914 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
14d
Days
Class 2
Risk

K232914 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500). 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 October 3, 2023 after a review of 14 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 K232914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2023
Decision Date October 03, 2023
Days to Decision 14 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
114d faster than avg
Panel avg: 128d · This submission: 14d
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 63
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K232914.
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700
K251666 · STERIS Corporation · Apr 2026
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
K230582 · STERIS Corporation · Mar 2023
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
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
K210737 · STERIS Corporation · May 2021