DeviceClearance

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 +1 more— 510(k) K251666

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K251666 for SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 +1 more, Substantially Equivalent on 2026-04-08. Applicant: STERIS Corporation. Device class: 2.

Summary

This clearance covers two STERIS liquid chemical sterilant processing systems: SYSTEM 1E (Model P6700) and SYSTEM 1 endo (Model P6900). Hospitals use them to sterilize heat-sensitive reusable devices between patients, flexible endoscopes above all. Product code MED covers sterilants for medical devices.

Class II, 21 CFR 880.6885. The General Hospital panel reviewed it as a Traditional 510(k).

STERIS filed from Mentor, Ohio. Review took 313 days (May 30, 2025 to April 8, 2026). Sterilant claims need extensive efficacy and materials compatibility testing, and FDA goes through that data closely.

Clearance details

Device name as filed
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900
Applicant
STERIS Corporation
Product code
Code MED
Device class
Class 2
Regulation
21 CFR 880.6885
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mentor, OH, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.