Cleared Traditional

K980014 - THE SYSTEM 2S STEAM STERILIZER

K980014 is the FDA 510(k) clearance for THE SYSTEM 2S STEAM STERILIZER by STERIS Corporation. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K980014 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
133d
Days
Class 2
Risk

K980014 is an FDA 510(k) clearance for the THE SYSTEM 2S STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Erie, US). The FDA issued a Cleared decision on May 15, 1998 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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.

View all STERIS Corporation devices

Submission Details

510(k) Number K980014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date May 15, 1998
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 66
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K980014.
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992