Cleared Traditional

K980014 - THE SYSTEM 2S STEAM STERILIZER

K980014 is an FDA 510(k) clearance for THE SYSTEM 2S STEAM STERILIZER, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K980014

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.

FLE Device Classification - Class 2, Special Controls

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 123
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K980014.
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · Scican · Jan 1999
EAGLE CENTURY STEAM STERILIZER
K964332 · Amsco Intl., Inc. · Jun 1998
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE
K962903 · Prestige Medical Corp. · Mar 1998
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
K973225 · Getinge/Castle, Inc. · Feb 1998
TUTTNAUER PREVACUUM TABLE AUTOCLAVE
K962282 · Tuttnauer U.S.A Co, Ltd. · Nov 1997