Cleared Traditional

K251666 - SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700

Also marketed or referenced as:
SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

K251666 is an FDA 510(k) clearance for SYSTEM 1E Liquid Chemical Sterilant Pro..., 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 313-day FDA review.

K251666 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
313d
Days
Class 2
Risk

K251666 is an FDA 510(k) clearance for the SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700. 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 April 8, 2026 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K251666

510(k) Number K251666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2025
Decision Date April 08, 2026
Days to Decision 313 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
184d slower than avg
Panel avg: 129d · This submission: 313d
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 46
Devices cleared under the same product code (MED) and FDA review panel - the closest regulatory comparables to K251666.
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)
K232914 · STERIS Corporation · Oct 2023
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
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